[Federal Register Volume 60, Number 109 (Wednesday, June 7, 1995)]
[Proposed Rules]
[Pages 30032-30037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13831]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 872

[Docket No. 95N-0033]


Dental Devices; Effective Date of Requirement for Premarket 
Approval of Endodontic Dry Heat Sterilizer

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; opportunity to request a change in 
classification.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to require 
the filing of a premarket approval application (PMA) or a notice of 
completion of a product development protocol (PDP) for the endodontic 
dry heat sterilizer, a medical device. The agency also is summarizing 
its proposed findings regarding the degree of risk of illness or injury 
designed to be eliminated or reduced by requiring the device to meet 
the statute's approval requirements, and the benefits to the public 
from use of the device. In addition, FDA is announcing the opportunity 
for interested persons to request the agency to change the 
classification of the device based on new information.

DATES: Written comments by September 5, 1995; requests for a change in 
classification by June 22, 1995. FDA intends that, if a final rule 
based on this proposed rule is issued, PMA's will be required to be 
submitted within 90 days of the effective date of the final rule.

ADDRESSES: Submit written comments or requests for a change in 
classification to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices 
and Radiological Health (HFZ-84), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850, 301-594-4765.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 513 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 360c) requires the classification of medical devices into 
one of three regulatory classes: Class I (general controls), class II 
(special controls), and class III (premarket approval). Generally, 
devices that were on the market before May 28, 1976, the date of 
enactment of the Medical Device Amendments of 1976 (the amendments) 
(Pub. L. 94-295), and devices marketed on or after that date that are 
substantially equivalent to such devices, have been classified by FDA. 
For the sake of convenience, this preamble refers to both the devices 
that were on the market before May 28, 1976, and the substantially 
equivalent devices that were marketed on or after that date as 
``preamendments devices.''
    Section 515(b)(1) of the act (21 U.S.C. 360e(b)(1)) establishes the 
requirement that a preamendments device that FDA has classified into 
class III is subject to premarket approval. A preamendments class III 
device may be commercially distributed without an approved PMA or 
notice of completion of a PDP until 90 days after FDA issues a final 
rule requiring premarket approval for the device, or 30 months after 
final classification of the device under section 513 of the act, 
whichever is later. Also, a preamendments device, subject to the 
rulemaking procedure under section 515(b) of the act, is not required 
to have an approved investigational device exemption (IDE) (21 CFR part 
812) contemporaneous with its interstate distribution until the date 
identified by FDA in the final rule requiring the submission of a PMA 
for the device.
    Section 515(b)(2)(A) of the act provides that a proceeding to issue 
a final rule to require premarket approval shall be initiated by 
publication of a notice of proposed rulemaking containing: (1) The 
proposed rule; (2) proposed findings with respect to the degree of risk 
of illness or injury designed to be eliminated or reduced by requiring 
the device to have an approved PMA or a declared completed PDP and the 
benefit to the public from the use of the device; (3) an opportunity 
for the submission of comments on the proposed rule and the proposed 
findings; and (4) an opportunity to request a change in the 
classification of the device based on new information relevant to the 
classification of the device.
    Section 515(b)(2)(B) of the act provides that if FDA receives a 
request for a change in the classification of the device within 15 days 
of the publication of the notice, FDA shall, within 60 days of the 
publication of the notice, consult with the appropriate FDA advisory 
committee and publish a notice denying the request for change of 
classification or announcing its intent to initiate a proceeding to 
reclassify the device under section 513(e) of the act. If FDA does not 
initiate such a proceeding, section 515(b)(3) of the act provides that 
FDA shall, after the close of the [[Page 30033]] comment period on the 
proposed rule and consideration of any comments received, issue a final 
rule to require premarket approval, or publish a notice terminating the 
proceeding. If FDA terminates the proceeding, FDA is required to 
initiate reclassification of the device under section 513(e) of the 
act, unless the reason for termination is that the device is a banned 
device under section 516 of the act (21 U.S.C. 360f).
    If a proposed rule to require premarket approval for a 
preamendments device is made final, section 501(f)(2)(B) of the act (21 
U.S.C. 351(f)(2)(B)) requires that a PMA or a notice of completion of a 
PDP for any such device be filed within 90 days of the date of issuance 
of the final rule or 30 months after final classification of the device 
under section 513 of the act, whichever is later. If a PMA or a notice 
of completion of a PDP is not filed by the later of the two dates, 
commercial distribution of the device is required to cease. The device 
may, however, be distributed for investigational use if the 
manufacturer, importer, or other sponsor of the device complies with 
the IDE regulations. If a PMA or a notice of completion of a PDP is not 
filed by the later of the two dates, and no IDE is in effect, the 
device is deemed to be adulterated within the meaning of section 
501(f)(1)(A) of the act, and subject to seizure and condemnation under 
section 304 of the act (21 U.S.C. 334) if its distribution continues. 
Shipment of the device in interstate commerce will be subject to 
injunction under section 302 of the act (21 U.S.C. 332), and the 
individuals responsible for such shipment will be subject to 
prosecution under section 303 of the act (21 U.S.C. 333). FDA has in 
the past requested that manufacturers take action to prevent the 
further use of devices for which no PMA has been filed and may 
determine that such a request is appropriate for endodontic dry heat 
sterilizers.
    The act does not permit an extension of the 90-day period after 
issuance of a final rule within which an application or a notice is 
required to be filed. The House Report on the amendments states that:

    the thirty month `grace period' afforded after classification of 
a device into class III * * * is sufficient time for manufacturers 
and importers to develop the data and conduct the investigations 
necessary to support an application for premarket approval.

(H. Rept. 94-853, 94th Cong., 2d sess. 42 (1976).)

A. Classification of Endodontic Dry Heat Sterilizers

    In the Federal Register of August 12, 1987 (52 FR 30082), FDA 
issued a final rule (Sec. 872.6730 (21 CFR 872.6730)) classifying the 
endodontic dry heat sterilizer into class III. The preamble to the 
proposal to classify the device published in the Federal Register of 
December 30, 1980 (45 FR 86155), included the recommendation of the 
Dental Device Classification Panel (the panel), of the Medical Devices 
Advisory Committee, an FDA advisory committee, regarding the 
classification of the device.
    The panel recommended that the device be in class III (premarket 
approval) because the device presented an unreasonable risk of illness 
or injury. According to the panel, the devices failed to sterilize 
adequately various endodontic and dental instruments. The panel felt 
that the failures could be the result of: (1) The device not reaching 
and maintaining an adequate temperature because of a faulty thermostat 
or (2) the result of unequal heat distribution by the glass beads 
throughout the well despite sufficient heat. The panel believed that it 
was not possible to establish an adequate performance standard for the 
device because satisfactory performance had never been demonstrated. 
The panel recommended the device to be subject to premarket approval to 
assure that manufacturers of the device demonstrate satisfactory 
performance and that further study was necessary to determine the 
causes of the device's ineffectiveness.
    FDA agreed with the panel's recommendation that endodontic dry heat 
sterilizers be classified into class III. FDA believed that there was 
an unreasonable risk of illness or injury because of the potential 
failure of the device to sterilize dental instruments adequately. FDA 
believed that there was inadequate information to determine if general 
controls or a performance standard would provide reasonable assurance 
of safety and effectiveness.

B. Dates New Requirements Apply

    In accordance with section 515(b) of the act, FDA is proposing to 
require that a PMA or a notice of completion of a PDP be filed with the 
agency for the endodontic dry heat sterilizer within 90 days after 
issuance of any final rule based on this proposal. An applicant whose 
device was legally in commercial distribution before May 28, 1976, or 
has been found by FDA to be substantially equivalent to such a device, 
will be permitted to continue marketing the endodontic dry heat 
sterilizer during FDA's review of the PMA or notice of completion of 
the PDP. FDA intends to review any PMA for the device within 180 days, 
and any notice of completion of a PDP for the device within 90 days of 
the date of filing. FDA cautions that, under section 515(d)(1)(B)(i) of 
the act, FDA may not enter into an agreement to extend the review 
period for a PMA beyond 180 days unless the agency finds that `` * * * 
the continued availability of the device is necessary for the public 
health.''
    FDA intends that, under Sec. 812.2(d), the preamble to any final 
rule based on this proposal will state that, as of the date on which a 
PMA or a notice of completion of a PDP is required to be filed, the 
exemptions in Sec. 812.2 (c)(1) and (c)(2) from the requirements of the 
IDE regulations for preamendments class III devices will cease to apply 
to any endodontic dry heat sterilizer which is: (1) Not legally on the 
market on or before that date; (2) legally on the market on or before 
that date but for which a PMA or notice of completion of a PDP is not 
filed by that date; or (3) for which PMA approval has been denied or 
withdrawn.
    If a PMA or a notice of completion of a PDP for the endodontic dry 
heat sterilizer is not filed with FDA within 90 days after the date of 
issuance of any final rule requiring premarket approval for the device, 
commercial distribution of the device must cease. The device may be 
distributed for investigational use only if the requirements of the IDE 
regulations are met. FDA would not consider an investigation of an 
endodontic glass bead sterilizer to pose a significant risk as defined 
in the IDE regulation provided that instruments processed in the device 
are terminally sterilized by a sterilization process which can be 
biologically monitored, such as steam, ethylene oxide, or dry heat. If 
the investigation cannot be so designed, the investigation would 
constitute a significant risk. The requirements for significant risk 
devices include submitting an IDE application to FDA for its review and 
approval. An approved IDE is required to be in effect before an 
investigation of the device may be initiated or continued. FDA, 
therefore, cautions that IDE applications should be submitted to FDA at 
least 30 days before the end of the 90-day period after the final rule 
is published to avoid interrupting investigations.

C. Description of Device

    Endodontic dry heat sterilizers are small electrically heated dry 
heat sterilizers with a central well containing a heat transfer medium. 
The types of [[Page 30034]] heat transfer media used in these units 
have included glass beads, molten metal, metal beads, and salt. The 
instruments which are to be sterilized are inserted directly into the 
heat transfer medium. The units are defined in Sec. 872.6730 as devices 
used to sterilize endodontic and other dental instruments by the 
application of dry heat which is supplied by the glass beads which have 
been heated by electricity.
    The proposed rule to require premarket approval of the endodontic 
dry heat sterilizer applies to devices that were being commercially 
distributed before May 28, 1976, and to devices that were introduced 
into commercial distribution since that date which have been found to 
be substantially equivalent to predicate endodontic dry heat 
sterilizers.

D. Proposed Findings With Respect to Risks and Benefits

    As required by section 515(b) of the act, FDA is publishing its 
proposed findings regarding: (1) The degree of risk of illness or 
injury designed to be eliminated or reduced by requiring endodontic dry 
heat sterilizers to have an approved PMA or a declared completed PDP; 
and (2) the benefits to the public from the use of the device.

E. Risk Factors

    The panel identified the primary risk to health as infection by 
stating that ``The inability of the device to sterilize adequately 
endodontic and other dental instruments may lead to transmission of 
microorganisms among patients and subsequent spread of infection.''
    A review of the literature on endodontic dry heat sterilizers has 
identified the following problems associated with the use of these 
devices which contribute to the inability of endodontic dry heat 
sterilizers to sterilize instruments, including general medical 
instruments.
1. Temperature Variation Within the Well
    There are many reports in the literature describing the temperature 
variation found within the wells of glass bead sterilizers (Refs. 2, 3, 
4, 7, 10, and 11). Engelhardt et al. (Ref. 4) measured the temperature 
distribution in four brands of glass bead sterilizers at two different 
sites from the center and at six different depths in the well. He 
reported that the temperature within the well varied significantly 
depending upon location. The temperature was highest closest to the 
wall and midway down from the surface (Ref. 4). Corner also reported 
that near the periphery of the well the temperature varied by as much 
as 10  deg.C over time (Ref. 5). According to Ingle, glass bead 
sterilizers should not be used as a substitute for dry heat convection 
or steam sterilizers because of the temperature variations (Ref. 7).
2. Lack of Methods to Monitor the Recommended Exposure Times for 
Sterilization of the Instruments
    The manufacturers' recommended exposure times for sterilization of 
instruments vary from as short as 2 seconds to 45 seconds for 
sterilizers whose purported operating temperatures are from 218  deg.C 
to 260  deg.C. However, location of the instruments in the well, the 
size and mass of the instruments, the number of instruments, and the 
shape of the instruments must be factored into the amount of time 
required for sterilization. Larger instruments composed of more metal 
take more time to heat than smaller instruments. Koehler reported that 
the time required to raise an instrument's temperature was dependent 
upon its size. Small instruments such as root canal files heated 
rapidly, while large instruments such as cotton pliers never reached 
the specified operating temperature (Ref. 6). Corner reported that 
instruments such as forceps, scalpels, spatulas, and scissors 
sterilized in rapid succession caused the temperature in the well to 
drop an average of 7  deg.C for each instrument and that it took 15 
minutes for the temperature of the well to recover (Ref. 2). Smith 
reported sterilization times of 15 seconds to kill orthodontic bands 
contaminated with Staphylococcus albus and 45 seconds for bands 
contaminated with Bacillus subtilis spores; but if five bands were 
sterilized simultaneously, then the sterilization times doubled (Ref. 
10). Fahid reported that a No. 60 file, which was the largest file 
tested in the study, was the most difficult to sterilize. The 
difficulty was attributed to two factors: the large mass of the file, 
and the air trapped in the deep trough since air is a poor heat 
conductor (Ref. 5). Engelhardt described sterilization times for 
endodontic instruments ranging from 15 to more than 100 seconds in 
glass bead sterilizers, and in some cases, the 100 seconds were not 
sufficient to achieve sterilization (Ref. 4). Schutt et al. found that 
it took 60 seconds to sterilize dental burs. He also emphasized that 
the temperature at the depth of the immersion of the burs should be 
measured and that the minimum temperature should be at least 175  deg.C 
at 2 millimeters (mm) below the surface and 240  deg.C at 15 mm below 
the surface (Ref. 9). It has been reported in the literature that glass 
bead sterilizers have been shown to be effective only with small 
instruments that can be imbedded into the heat transfer media and that 
their effectiveness has not been demonstrated for instruments of larger 
bulk. The insertion of large instruments would reduce the temperature 
of the glass beads below the minimum temperature required for 
sterilization (Ref. 1). Heat conduction in a large, partially imbedded 
device would be variable.
    Precleaning of the instruments before insertion into the glass bead 
sterilizer is critical to the effectiveness of the device. Engelhardt 
demonstrated that if endodontic instruments were contaminated with a 
protein load (blood), the time required for sterilization was more than 
doubled. Such adverse conditions can easily be found in infected or 
gangrenous pulp. Spores, which are more resistant to sterilization 
processes than vegetative organisms, have been found in the oral cavity 
and cultured from pulp material (Ref. 4).
3. Lack of Methods to Monitor the Performance/Sterilization Efficacy of 
the Device
    There are no identified methods for the routine monitoring of the 
sterilization efficacy of the endodontic dry heat sterilizer such as 
the ones which exist with the traditional sterilization methods, i.e., 
steam autoclaves, hot air dry heat sterilizers, or ethylene oxide 
sterilizers. Chemical and biological indicators are available for 
routine monitoring of the efficacy of the cycle parameters and for the 
validation of the process specifications for these traditional 
sterilizers. The data in the literature, as noted above, suggest that 
the user can not be assured that instruments inserted into an 
endodontic dry heat sterilizer will be reliably exposed to the minimum 
cycle parameters required for sterilization, i.e., exposure of the 
device to a set temperature for a specified time.
4. Variability of the Warm-up Times for Glass Bead Sterilizers
    Reported warm-up times for these devices range from 15 minutes to 
50 minutes with the average of 15-20 minutes. However, Corner reported 
that it took up to 30 minutes for the temperature of the glass beads to 
stabilize even though the manufacturer claimed that the device reached 
operating temperature within 10 minutes (Ref. 2). [[Page 30035]] 
5. Maintenance of Sterility After Removal From the Device
    The instructions for use for most of the devices do not instruct 
the user on the proper procedure to remove instruments from the device, 
and on how to maintain sterility of the instruments or the processed 
portion of the instrument during the cool down period. There also 
exists the possibility that the heat transfer medium could serve as a 
source of contamination between patients. Because of the reported 
temperature gradients within the wells, there exists the possibility 
that heat resistant microorganisms could survive in the cooler regions 
near the top of the well and contaminate the instruments used upon the 
next patient as they are removed from the well. Furthermore, because 
endodontic dry heat sterilizers only process that portion of the 
instrument which has been inserted into the glass beads, there is the 
potential of contaminating a sterile field with a device which had not 
been properly processed.
6. Possibility of the Heat Transfer Medium Remaining Upon The Devices
    Occasionally the heat transfer media has been observed to adhere to 
wet instruments. If the particles are not detected before the devices 
are inserted into the site, then they could cause blockage of the wound 
site or other adverse effects. This would cause significant problems if 
the heat transfer media were glass beads or molten metal (Ref. 1).

F. Benefit of the Devices

    The endodontic dry heat sterilizer could be used to decontaminate 
endodontic instruments during a procedure on a single patient provided 
the instruments are properly cleaned to remove organic debris before 
insertion into the unit. In theory the number of microorganisms that 
would be introduced into the same site or into a new site on the same 
patient during a single procedure would be reduced. Once the procedure 
is over, the instruments should be processed using traditional methods 
of decontamination and sterilization before use in the next patient.

G. Need for Information for Risk/Benefit Assessment of the Device

    The data in the literature indicate the lack of uniform 
sterilization parameters among the various glass bead sterilizers which 
have been marketed. Because of the temperature variation found within 
the wells of glass bead sterilizers, exposure of an instrument to an 
adequate sterilizing temperature is difficult to determine and must be 
confirmed independently for each instrument. Also determination of the 
sterilization exposure time is dependent upon instrument size and mass. 
As Koehler noted, some instruments never reach the appropriate 
temperature because of their size and mass (Ref. 6); and, as noted in 
the American Dental Association's ``Accepted Dental Therapeutics,'' 
40th ed., endodontic dry heat sterilizers are not appropriate for large 
bulk instruments (Ref. 1).
    Review of the claims being made for these devices suggests that 
manufacturers are expanding the claims beyond those originally defined 
in Sec. 872.6730. The claims have been expanded to include the 
sterilization of general medical instruments and electrolysis and 
acupuncture needles, and to devices not regulated by FDA such as 
manicurist's instruments. The claims imply that these devices can be 
used as a substitute for the traditional methods of sterilization. 
Scarlett noted that endodontic dry heat sterilizers are not 
sterilizers, but are decontaminating devices and that they should not 
be used to sterilize instruments between patients (Ref. 8). No system 
exists for (1) Monitoring the exposure of the instrument to 
sterilization conditions, or (2) demonstrating that the sterilization 
exposure parameters have been achieved within the well. Only the 
portion of the instrument which is inserted into the heat transfer 
medium has the potential of being sterilized; the portion which is not 
inserted into the glass beads is not sterilized. The use of endodontic 
dry heat sterilizers with general medical instruments and with the 
implication as a substitute sterilization method raises serious safety 
and effectiveness questions which the manufacturers of these devices 
have not adequately addressed. There is the serious risk of infection 
through the use of inadequately processed instruments.
    FDA believes that sufficient information may exist regarding the 
risks and benefits associated with the device, but the information must 
be assembled in such a way as to enable FDA to determine if the 
information provides reasonable assurance of the safety and 
effectiveness of the device for its intended use as defined in 21 CFR 
860.7.
    FDA classified the endodontic dry heat sterilizer into class III 
because it determined that insufficient information existed to 
determine that general controls would provide reasonable assurance of 
the safety and effectiveness of the device or to establish a 
performance standard to provide such assurance. FDA has determined that 
the special controls that may now be applied to class II devices under 
the Safe Medical Devices Act of 1990 also would not provide such 
assurance. FDA has weighed the probable risks and benefits to the 
public health from the use of the device and believes that the 
literature reports and other information discussed above present 
evidence of significant risks associated with use of the device. These 
risks must be addressed by the manufacturers of endodontic dry heat 
sterilizers. FDA believes that the endodontic dry heat should undergo 
premarket approval to establish effectiveness and to determine whether 
the benefits to the patient are sufficient to outweigh any risk.

II. PMA Requirements

    A PMA for this device must include the information required by 
section 515(c)(1) of the act. Such a PMA should also include a detailed 
discussion of the risks identified above, as well as a discussion of 
the effectiveness of the device for which premarket approval is sought.
    A PMA should include valid scientific evidence obtained from well-
controlled studies, with detailed data, in order to provide reasonable 
assurance of the safety and effectiveness of the endodontic dry heat 
sterilizer for its intended use. The data must include the following 
information:
    a. A general description of the sterilizer including its 
specifications, process parameters and process monitors;
    b. An overview of the sterilization process with accompanying 
charts, graphs, or other visuals explaining all parameters;
    c. A description of any test packs used in validating the 
performance of the endodontic dry heat sterilizer and in routine 
monitoring of the device;
    d. Physical tests which demonstrate that the sterilizer achieves 
and maintains the physical process lethality conditions within 
specifications. The testing should describe how the process parameters 
and specifications were determined;
    e. The microbiological performance tests must demonstrate that the 
device can sterilize to an acceptable sterilization assurance level all 
medical products identified in the labeling when used in accordance 
with the directions for use. The tests should be consistent with those 
used to validate sterilization processes including simulated and actual 
use tests;
    f. Material compatibility tests must show that the medical devices 
identified in the labeling are compatible with the 
[[Page 30036]] sterilization process of the endodontic dry heat 
sterilizer; and
    g. Final qualification tests from at least three consecutive runs 
under worst case loading conditions as indicated in the labeling.
    Additional information about the validation of sterilization 
processes can be found in: ``Guidance on Premarket Notification 
(510(k)) Submissions for Sterilizers Intended for Use in Health Care 
Facilities'' (available upon request from the Center for Devices and 
Radiological Health, Division of Small Manufacturers Assistance (HFZ-
220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 
20850); the American Association of Medical Instrumentation's (AAMI) 
voluntary standards describing the validation requirements for 
sterilization processes; and the publication entitled ``Sterile Medical 
Devices, A GMP Workshop Manual, 4th Ed., HHS Publication (FDA) 84-4147.
    The PMA should contain a detailed discussion with supporting 
simulated- and in-use studies, as described in the above guidance, of: 
(1) All risks that have been identified in this proposed rule; and (2) 
the effectiveness of the specific endodontic dry heat sterilizer that 
is the subject of the application. In addition, the submission should 
contain all data and information on: (1) Risks known to the applicant 
that have not been identified in this proposed rule; (2) summaries of 
all existing simulated- and in-use data from investigations on the 
safety and effectiveness of the device for which premarket approval is 
sought; and (3) the results of simulated- and in-use studies conducted 
by or for the applicant. Applicants should submit any PMA in accordance 
with the FDA's ``Guideline for the Arrangement and Content of a PMA 
Application.'' The guideline is available from the Center for Devices 
and Radiological Health, Division of Small Manufacturers Assistance 
(address above).

III. Comments

    Interested persons may, on or before September 5, 1995, submit to 
the Dockets Management Branch (address above) written comments 
regarding this proposal. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments or 
requests are to be identified with the docket number found in brackets 
in the heading of this document. Received comments and requests may be 
seen in the office above between 9 a.m. and 4 p.m., Monday through 
Friday.

IV. Opportunity to Reguest a Change in Classification

    Before requiring the filing of a PMA or a notice of completion of a 
PDP for a device, FDA is required by section 515 (b)(2)(A)(i) through 
(b)(2)(A)(iv) of the act and 21 CFR 860.132 to provide an opportunity 
for interested persons to request a change in the classification of the 
device based on new information relevant to its classification. Any 
proceeding to reclassify the device will be under the authority of 
section 513(e) of the act.
    A request for a change in the classification of the endodontic dry 
heat sterilizer is to be in the form of a reclassification petition 
containing the information required by Sec. 860.123 (21 CFR 860.123), 
including new information relevant to the classification of the device, 
and shall, under section 515(b)(2)(B) of the act, be submitted by June 
22, 1995.
    The agency advises that, to ensure timely filing of any such 
petition, any request should be submitted to the Dockets Management 
Branch (address above) and not to the address provided in 
Sec. 860.123(b)(1). If a timely request for a change in the 
classification of the endodontic dry heat sterilizer is submitted, the 
agency will, by August 7, 1995, after consultation with the appropriate 
FDA advisory committee and by an order published in the Federal 
Register, either deny the request or give notice of its intent to 
initiate a change in the classification of the device in accordance 
with section 513(e) of the act and 21 CFR 860.130 of the regulations.

V. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.

1. American Dental Association, ``Accepted Dental Therapeutics,'' 
40th ed., pp. 138-139, Chicago, IL, 1984.
2. Corner, G. A., ``An Assessment of the Performance of a Glass Bead 
Sterilizer,'' Journal of Hospital Infection, 10:308-311, 1987.
3. Dayoub, M. B., and M. J. Devine, ``Endodontic Dry-Heat Sterilizer 
Effectiveness,'' Journal of Endodontics, 2:343-344, 1976.
4. Engelhardt, M. P., L. Grun, and H. Dahl, ``Factors Affecting 
Sterilization in Glass Bead Sterilizers,'' Journal of Endodontics, 
10:454-470, 1984.
5. Fahid, A., and J. F. Tainter, ``The Influence of File Size, 
Cleaning, and Time on the Effectiveness of Bead Sterilizers,'' Oral 
Surgery, 58:443-445, 1984.
6. Koehler, H. M., and J. J. Hefferren, ``Time-Temperature Relations 
of Dental Instruments Heated in Root-Canal Instrument Sterilizers,'' 
Journal of Dental Research, 41:182-195, 1962.
7. Ingle, J. I., Endodontics, 3d Ed., Philadelphia, Lea & Febiger, 
pp. 615-616.
8. Jakush, J., ``Infection Control Procedures and Products: Cautions 
and Common Sense,'' Journal of The American Dental Association, 
117:293-301, 1988.
9. Schutt, R. W., and W. J. Starsiak, ``Glass Bead Sterilization of 
Surgical Dental Burs,'' International Journal of Oral and 
Maxillofacial Surgery, 19:250-251, 1990.
10. Smith, G. E., ``Glass Bead Sterilization of Orthodontic Bands,'' 
American Journal of Orthodontics Dentofacial Orthopedics, 90:243-
249, 1986.
11. Windeler, A. S., and R. G. Walter, ``The Sporicidal Activity of 
Glass Beads Sterilizers,'' Journal of Endodontics, 1:273-275, 1975.

VI. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(8) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

VII. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the proposed 
rule is not a significant regulatory action as defined by the Executive 
Order and so is not subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because PMA's for this device could have been 
required by FDA as early as February 12, 1990, and because firms that 
distributed this device prior to May 28, 1976, or whose device has been 
found by FDA to be substantially equivalent will be permitted to 
continue marketing the endodontic dry heat sterilizer during FDA's 
review of the PMA or notice of completion of the [[Page 30037]] PDP, 
the agency certifies that the proposed rule will not have a significant 
economic impact on a substantial number of small entities.
    Therefore, under the Regulatory Flexibility Act, no further 
analysis is required.

List of Subjects in 21 CFR Part 872

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 872 be amended as follows:

PART 872--DENTAL DEVICES

    1. The authority citation for 21 CFR part 872 is revised to read as 
follows:

    Authority: Secs. 501, 510, 513, 515, 520, 522, 701 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 
360e, 360j, 360l, 371).

    2. Section 872.6730 is amended by revising paragraph (c) to read as 
follows:

Sec. 872.6730

  Endodontic dry heat sterilizer.

* * * * *

    (c) Date premarket approval application (PMA) or notice of 
completion of product development protocol (PDP) is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (90 days after the effective date 
of a final rule based on this proposed rule), for any endodontic dry 
heat sterilizer that was in commercial distribution before May 28, 
1976, or that has on or before (90 days after the effective date of a 
final rule based on this proposed rule), been found to be substantially 
equivalent to the endodontic dry heat sterilizer that was in commercial 
distribution before May 28, 1976. Any other endodontic dry heat 
sterilizer shall have an approved PMA or declared completed PDP in 
effect before being placed in commercial distribution.

    Dated: May 24, 1995.

D. B. Burlington,

Director, Center for Devices and Radiological Health.

[FR Doc. 95-13831 Filed 6-6-95; 8:45 am]
BILLING CODE 4160-01-P