[Federal Register Volume 67, Number 93 (Tuesday, May 14, 2002)]
[Proposed Rules]
[Pages 34416-34420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-12041]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 21 CFR Part 872

[Docket No. 02N-0114]


Dental Devices; Reclassification of Root-Form Endosseous Dental 
Implants and Endosseous Dental Implant Abutments

Agency: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
reclassify from class III to class II root-form endosseous dental 
implants intended to be surgically placed in the bone of the upper or 
lower arches to provide support for prosthetic devices, such as 
artificial teeth, in order to restore the patient's chewing function. 
FDA is also proposing to reclassify endosseous dental implant 
abutments, which are separate components that are attached to the 
implant and intended to aid in prosthetic rehabilitation from class III 
to class II. This reclassification is being proposed on the Secretary 
of Health and Human Services (the Secretary's) own initiative based on 
new information. The agency is taking this action under the Federal 
Food, Drug, and Cosmetic Act (the act), as amended by the Medical 
Device Amendments of 1976 (the 1976 amendments), the Safe Medical 
Devices Act of 1990 (the SMDA), and the Food and Drug Administration 
Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the 
Federal Register, FDA is publishing a notice of availability of a draft 
guidance document that would serve as the special control if this 
proposal becomes final.

DATES:  Submit written or electronic comments by August 12, 2002. See 
section XIII of this document for the proposed effective date of a 
final rule based on this document.

ADDRESSES:  Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Angela E. Blackwell, Center for 
Devices and Radiological Health (HFZ-480), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-
8879.

SUPPLEMENTARY INFORMATION:

I. Background (Regulatory Authorities)

    The act (21 U.S.C. 301 et seq.), as amended by the 1976 amendments 
(Public Law 94-295), the SMDA (Public Law 101-629) and FDAMA (Public 
Law 105-115), established a comprehensive system for the regulation of 
medical devices intended for human use. Section 513 of the act (21 
U.S.C. 360c) established three categories (classes) of devices, 
depending on the regulatory controls needed to provide reasonable 
assurance of their safety and effectiveness. The three categories of 
devices are class I (general controls), class II (special controls), 
and class III (premarket approval).
    Under section 513 of the act, devices that were in commercial 
distribution before May 28, 1976 (the date of enactment of the 1976 
amendments), generally referred to as preamendments devices, are 
classified after FDA has: (1) Received a recommendation from a device 
classification panel (an FDA advisory committee); (2) published the 
panel's recommendation for comment, along with a proposed regulation 
classifying the device; and (3) published a final regulation 
classifying the device. FDA has classified most preamendments devices 
under these procedures.
    Devices that were not in commercial distribution prior to May 28, 
1976, generally referred to as postamendments devices, are classified 
automatically by statute (section 513(f) of the act) into class III 
without any FDA rulemaking process. Those devices remain in class III 
and require premarket approval, unless and until: (1) The device is 
reclassified into class I or II; (2) FDA issues an order classifying 
the device into class I or II in accordance with new section 513(f)(2) 
of the act, as amended by FDAMA; or (3) FDA issues an order finding the 
device to be substantially equivalent, under section 513(i) of the act, 
to a predicate device that does not require premarket approval. The 
agency determines whether new devices are substantially equivalent to 
previously offered devices by means of premarket notification 
procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR 
part 807 of the regulations.
    A preamendments device that has been classified into class III may 
be marketed, by means of premarket notification procedures, without 
submission of a premarket approval application (PMA) until FDA issues a 
final regulation under section 515(b) of the act (21 U.S.C. 360e(b)) 
requiring premarket approval.
    Reclassification of classified preamendments devices is governed by 
section 513(e) of the act. This section provides that FDA may, by 
rulemaking, reclassify a device (in a proceeding that parallels the 
initial classification proceeding) based upon ``new information.'' The 
reclassification can be initiated by FDA or by the petition of an 
interested person. The term ``new information,'' as used in section 
513(e) of the act, includes information developed as a result of a 
reevaluation of the data before the agency when the device was 
originally classified, as well as information not presented, not 
available, or not developed at that time. (See, e.g., Holland Rantos v. 
United States Department of Health, Education, and Welfare, 587 F.2d at 
1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th 
Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the agency is an 
appropriate basis for subsequent regulatory action where the 
reevaluation is made in light of newly available regulatory authority 
(see Bell v. Goddard, supra, 366 F.2d at 181; Ethicon , Inc. v. FDA, 
762 F. Supp. 382, 389-91 (D.D.C. 1991)), or in light of changes in 
``medical science.'' (See Upjohn v. Finch, supra, 422 F.2d at 951.) 
Regardless of whether data before the agency are past or new data, the 
``new information'' to support reclassification under section 513(e) of 
the act must be ``valid scientific evidence,'' as defined in section 
513(a)(3) of the act and 21 CFR 860.7(c)(2). (See, e.g., General 
Medical

[[Page 34417]]

Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Assoc. v. FDA, 
766 F.2d 592 (D.C. Cir.), cert. denied, 474 U.S. 1062 (1985)). FDA 
relies upon ``valid scientific evidence'' in the classification process 
to determine the level of regulation for devices. For the purpose of 
reclassification, the valid scientific evidence upon which the agency 
relies must be publicly available. Publicly available information 
excludes trade secret and/or confidential commercial information, e.g., 
nonpublic information in a pending PMA. (See section 520c of the act 
(21 U.S.C. 360j(c).)

II. Regulatory History of the Device

    In the Federal Register of August 12, 1987 (52 FR30082), FDA issued 
a final rule classifying endosseous implants into class III (21 CFR 
872.3640). The preamble to the proposal to classify the device (45 FR 
85962, December 30, 1980) included the recommendation of the Dental 
Devices Panel (the Panel) regarding the classification of the device. 
The Panel's recommendation included a summary of the reasons the device 
should be subject to premarket approval and identified certain risks to 
health presented by the device. The Panel also recommended under 
section 513(c)(2)(A) of the act that a high priority for the 
application of section 515 of the act be assigned to the endosseous 
dental implant.
    In the Federal Register of January 6, 1989 (54 FR 550 at 551), FDA 
issued a notice of intent to initiate proceedings to require premarket 
approval of 31 preamendments class III devices assigned a high priority 
by FDA for application of premarket approval requirements. Among other 
things, the notice described the factors FDA takes into account in 
establishing priorities for initiating proceedings under section 515(b) 
of the act for issuing final rules requiring that preamendments class 
III devices have approved PMAs or declared completed product 
development protocols (PDP)s. Using those factors, FDA declared that 
the endosseous implant, identified in 21 CFR 872.3640, had a high 
priority for initiating a proceeding to require premarket approval. 
Accordingly, FDA began a rulemaking proceeding to require that 
endosseous implants have an approved PMA or a PDP that has been 
declared completed.
    In the Federal Register of December 7, 1989 (54 FR 50592), FDA 
issued a proposed rule to require the filing of a PMA or a notice of 
completion of a PDP for the endosseous implant. In accordance with 
section 515(b)(2)(A) of the act, the agency summarized its proposed 
findings with respect to the degree of risk of illness or injury 
designed to be eliminated or reduced by requiring the device to meet 
premarket approval requirements, and the benefits to the public from 
the use of the device. The proposal also provided an opportunity for 
interested persons to comment on the proposed rule and to request a 
change in the classification of the device based on new information 
relevant to its classification. The period for requesting a change in 
the classification of the device closed on December 22, 1989. The 
period for commenting on the proposed rule closed on February 5, 1990.
    On December 12, 1989, FDA received a petition from the Dental 
Implant Manufacturers of America (DIMA) requesting a change in the 
classification of the root-form (i.e., screw, basket, solid and hollow 
cylinder types) and blade-form endosseous dental implants from class 
III to class II. The petition was limited to one-stage endosseous 
implants and the first stage component of the two-stage implant system. 
The petition's request included implants composed of commercially pure 
titanium, titanium alloy (Ti-6Al-4V), ceramic single crystal aluminum 
oxide, and ceramic, polycrystalline alumina. After a number of 
exchanges between FDA and DIMA to resolve several deficiencies, FDA 
referred the petition to the Panel for its recommendation on the 
requested change in classification. The Panel met on October 24, 1991, 
and voted to deny DIMA's petition (Ref. 1).
    Based on information provided by FDA for the October 24, 1991 
meeting, the Panel did recommend that screw-type root-form endosseous 
dental implants be reclassified to class II. The Panel stated that 
special controls would not be adequate to control some of the risks for 
other types of endosseous dental implants and recommended that all 
nonscrew-types remain in class III. In the years following this 
recommendation, additional clinical data have been reviewed by FDA and 
the agency believes all root-form endosseous dental implants can be 
reclassified.
    In accordance with section 513(e) of the act and 21 CFR 
860.130(b)(2), based on new information with respect to the device, 
FDA, on its own initiative, is proposing to reclassify the root-form 
endosseous dental implant from class III to class II when intended to 
be surgically placed in the bone of the upper or lower arches to 
provide support for prosthetic devices, such as artificial teeth, in 
order to restore the patient's chewing function. FDA is further 
proposing to reclassify endosseous dental implant abutments from class 
III to class II. Endosseous dental implants, other than root-form, 
remain in class III and will require the filing of a PMA or PDP at a 
future date.
    The Panel met again on November 4, 1997, with a continuation of the 
meeting on January 13, 1998. Based on new, publicly available 
information provided by FDA, the Panel recommended that all root-form 
endosseous dental implants and endosseous dental implant abutments be 
reclassified from class III to class II. The Panel believed that class 
II with special controls would provide reasonable assurance of safety 
and effectiveness.

III. Device Description

    An endosseous dental implant is a device made of titanium or 
titanium alloy and is uncoated, or coated with titanium or 
hydroxyapatite, intended to be surgically placed in the bone of the 
upper or lower jaw arches to provide support for prosthetic devices, 
such as artificial teeth, in order to restore the patient's chewing 
function. Endosseous dental implants are used to attach either 
removable or fixed prostheses (crowns, bridges, partial removable 
dentures, or complete removable dentures) and are inserted into either 
the maxillary or mandibular alveolar ridge.
    Endosseous dental implants can be defined as a one-stage or two-
stage implant system. These may be loaded after a period of healing or, 
in some patients for some indications, they may be loaded immediately. 
Endosseous dental implants can be further generically grouped into four 
geometrically distinct types: Basket, screw, solid cylinder, and hollow 
cylinder. These four groups are known as ``root-form'' implants. 
Several other geometrical types of implants have been marketed that do 
not fall within the description of one of these four types and those 
types are not root-form implants. FDA is proposing to change the 
classification of only the root-form types.
    Endosseous dental implant abutments are premanufactured prosthetic 
components directly connected to the endosseous implant and are used as 
an aid for prosthetic rehabilitation.

IV. Proposed Reclassification

    Although the Secretary is proposing reclassification on his own 
initiative, the agency provided new information to the Panel and asked 
for its recommendation regarding the reclassification of the devices. 
In a public meeting on January 13, 1998, the Panel unanimously 
recommended that the root-form endosseous dental implant

[[Page 34418]]

be reclassified from class III to class II. The Panel believed that 
class II with a special control guidance document, which includes 
references to relevant voluntary consensus standards and gives guidance 
on labeling, would provide reasonable assurance of safety and 
effectiveness.
    The Panel also recommended that endosseous implant abutments be 
reclassified from class III to class II. They recommended a separate 
classification from the root-form endosseous implants because the 
abutments are not considered implants. The Panel believed that class II 
with a special control guidance document that references relevant 
voluntary consensus standards would provide reasonable assurance of the 
safety and effectiveness of the device.

V. Risks to Health

    When endosseous dental implants were classified into class III (52 
FR 30082, August 12, 1987), the Panel and FDA identified several risks 
associated with endosseous dental implants for prosthetic attachment, 
including local soft tissue degeneration, hyperplasia, progressive bone 
resorption, exfoliation, local and systemic infection (including long 
term bacterial infection), damage to existing dentition, implant 
mobility, implant integrity, infectious endocarditis, paresthesia, 
perforation of the maxillary sinus, and perforation of the labial and 
lingual alveolar plates. Although the existence of the risks was well 
documented in numerous books and articles, the rate of occurrence was 
poorly documented.
    Although abutment integrity was not discussed as a specific risk at 
the 1987 Panel meeting, FDA believes that this risk is a component of 
implant integrity and, therefore, we have included abutment integrity 
as a risk associated with endosseous dental implant abutments.
    Since the classification of the device, additional data and 
information became available. Based on a review of the new data and 
information, the Panel, during an open public meeting on October 24, 
1991, identified certain risks (parasthesia, perforation of the 
maxillary sinus, perforation of the labial and lingual alveolar plates, 
infectious endocarditis and implant integrity), which had only been 
addressed for screw type implants by clinical studies. Therefore, they 
believed that special controls would not adequately address these 
concerns for all implants. They recommended only the screw type be 
reclassified into class II (Ref. 1).
    At the same meeting, the Panel concluded that the remaining risks 
of local soft tissue degeneration, hyperplasia, progressive bone 
resorption, exfoliation, local and systemic infection (including long-
term bacterial infection), damage to existing dentition, and implant 
mobility had been addressed by clinical studies for all types of dental 
implants.
    Although in 1991 the Panel stated that special controls could not 
adequately address the concern of implant integrity, they also stated 
that chemical and physical characterization and mechanical testing 
could partially control this risk with respect to fracture.
    When the Panel considered new information, at the November 4, 1997, 
and January 13, 1998, meetings, they concluded that several published 
clinical and animal studies (Refs. 4, 5, 6, 7, 8, and 9) showed that 
the occurrence and incidence of the risks discussed at the 1991 Panel 
meeting are now well known and are found to be low for all root-form 
devices and dental implant abutment devices (Refs. 2 and 3).
    On the basis of the new clinical studies and the Panel's two 
recommendations, FDA now believes that the root-form endosseous dental 
implants and endosseous dental implant abutments do not present a 
potential unreasonable risk to public health, and that special controls 
would provide reasonable assurance of the safety and effectiveness of 
the devices.

VI. Summary of Reasons for Reclassification

    After considering the new information and the Panel's 
recommendations, FDA believes that general controls are not sufficient 
to provide reasonable assurance of the safety and effectiveness of the 
device. FDA believes that the endosseous dental implants and endosseous 
dental implant abutments should be reclassified into class II because 
special controls, in addition to general controls, would provide 
reasonable assurance of the safety and effectiveness of the devices, 
and there is now sufficient information to establish special controls 
to provide such assurance.

VII. Summary of Data Upon Which the Recommendation is Based

    In addition to the potential risks to health of endosseous dental 
implants and endosseous dental implant abutments described in section V 
of this document, there is reasonable knowledge of the benefits of the 
device (Refs. 10 and 11). The devices provide increased chewing 
function and better appearance, resulting in an improved quality of 
patient life. Based on the available information, FDA believes the 
special control discussed in section VIII of this document is capable 
of providing reasonable assurance of the safety and effectiveness of 
the devices with regard to the identified risks to health of the 
device.

VIII. Special Controls

    In addition to general controls, FDA believes that the guidance 
document entitled ``Class II Special Controls Guidance Document: Root-
form Endosseous Dental Implants and Abutments; Draft Guidance for 
Industry and FDA'' is an adequate special control to address the 
potential risks to health described for the root-form endosseous dental 
implants and endosseous dental implant abutments.
    The guidance document would indicate when clinical data are 
appropriate and what engineering testing is needed. It will reference 
voluntary consensus standards that are relevant for these devices. It 
also will provide device specific labeling guidance. FDA believes that 
adherence to the guidance document would control implant and abutment 
fracture by providing guidance and reference to methodologies for 
chemical and physical characterization and mechanical testing.
    To receive a copy of ``Class II Special Controls Guidance Document: 
Root-form Endosseous Dental Implants and Abutments; Draft Guidance for 
Industry and FDA'' via fax machine, call CDRH Facts-on-Demand system at 
800-899-0381, or 301-827-0111 from a touch-tone telephone. Press 1 to 
access the system. At the second voice prompt, press 2, and then enter 
the document number (1389) followed by the pound sign (#). Then follow 
the remaining voice prompts to complete your request. The draft 
guidance is also available on the Internet and may be accessed at 
http://www.fda.gov/cdrh and at http://www.fda.gov/ohrms/dockets/defaults.htm.

IX. FDA's Tentative Findings

    FDA believes the root-form endosseous dental implants and 
endosseous dental implant abutments should be classified into class II 
because special controls, in addition to general controls, provide 
reasonable assurance of the safety and effectiveness of the device, and 
there is sufficient information to establish special controls to 
provide such assurance.

X. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this proposed 
reclassification action is of a type that

[[Page 34419]]

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.

XI. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 
1995 (Public Law 104-4). 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. Reclassification of these devices from class III to 
class II will relieve all manufacturers of these devices of the cost of 
complying with premarket approval requirements in section 515 of the 
act. Because reclassification will reduce regulatory cost with respect 
to these devices, it will impose no significant economic impact on any 
small entities, and it may permit small potential competitors to enter 
the marketplace by lowering their costs. The agency therefore certifies 
that this reclassification action, as issued, if finalized, will not 
have a significant economic impact on a substantial number of small 
entities. In addition, this reclassification action will not impose 
costs of $100 million or more on either the private sector or State, 
local, and tribal governments in the aggregate, and therefore a summary 
statement or analysis under section 202(a) of the Unfunded Mandates 
Reform Act of 1995 is not required.

XII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
information that is subject to review by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995. The special controls 
do not require the respondent to submit additional information.

XIII. Submission of Comments and Proposed Dates

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding this proposal by 
August 12, 2002. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday. FDA proposes 
that any final regulation based on this proposal become effective 30 
days after its date of publication in the Federal Register.

XIV. References

    The following references have been placed on display in the Dockets 
Management Branch (see ADDRESSES) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Transcript of the Dental Products Panel Meeting, October 24, 
1991.
    2. Transcript of the Dental Products Panel Meeting, November 4, 
1997.
    3. Transcript of the Dental Products Panel Meeting, January 13, 
1998.
    4. Buser, D., et al., ``Influence of Surface Characteristics on 
Bone Integration of Titanium Implants. A Histomorphometric Study in 
Miniature Pigs,'' Journal of Biomedical Materials Research, vol. 25, 
pp. 889-902, 1991.
    5. Carr, A. B., et al., ``Reverse Torque Failure of Screw-shaped 
Implants in Baboons: Baseline Data for Abutment Torque 
Application,'' International Journal of Oral and Maxillofacial 
Implants, vol. 10, pp. 167-174, 1995.
    6. Adell, R., et al., ``A Long-term Follow-up Study of 
Osseointegrated Implants in the Treatment of Totally Edentulous 
Jaws,'' International Journal of Oral and Maxillofacial Implants, 
vol. 5, pp. 347-359, 1990.
    7. O'Roark, W. L., ``Research Report: Improving Implant Survival 
Rates by Using a New Method of at Risk Analysis,'' International 
Journal of Oral Implantology, vol. 8, No. 1, pp. 31-57, 1991.
    8. Buser, D., et al., ``Long Term Evaluation of Nonsubmerged ITI 
Implants. Part 1: 8-year Life Table Analysis of a Prospective Multi-
center Study With 2359 Implants,'' Clinical Oral Implants Research, 
vol. 8, pp. 161-172, 1997.
    9. Block, M. S., J. N. Kent, ``Cylindrical HA-coated Implants--
8-year Observations,'' Compendium of Continuing Education Dentistry, 
Supplement 15, pp. 526-532, 1993.
    10. Proceedings of the 1996 World Workshop in Perisontics, 
Annals of Periodontology, vol. 1, No. 1, pp. 707-820, 1996.
    11. Misch, C. E., Contemporary Implant Dentistry, St. Louis, MO: 
Mosby, pp. 89-118, 1999.

List of Subjects in 21 CFR Part 872

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
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 continues to read as 
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    2. Section 872.3630 is added to subpart D to read as follows:


Sec. 872.3630  Endosseous dental implant abutment.

    (a) Identification. An endosseous dental implant abutment is a 
premanufactured prosthetic component directly connected to the 
endosseous dental implant and is intended for use as an aid for 
prosthetic rehabilitation.
    (b) Classification. Class II (special controls). The special 
control for this device is the FDA guidance document entitled ``Class 
II Special Controls Guidance Document: Root-form Endosseous Dental 
Implants and Abutments; Final Guidance for Industry and FDA.''
    3. Section 872.3640 is revised in subpart D to read as follows:


Sec. 872.3640  Endosseous dental implant.

    (a) Identification. An endosseous dental implant is a device made 
of a material such as titanium or titanium alloy intended to be 
surgically placed in the bone of the upper or lower jaw arches to 
provide support for prosthetic devices, such as artificial teeth, in 
order to restore a patient's chewing function.
    (b) Classification. (1) Class II (special controls). The special 
control for this device is the FDA guidance document entitled ``Class 
II Special Controls Guidance Document: Root-form Endosseous Dental 
Implants and Abutments; Final Guidance for Industry and FDA.''
    (2) Class III for endosseous dental implants other than the root-
form.
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established for the requirement for premarket 
approval for the devices described in paragraph (b)(2) of this section. 
See Sec. 872.3 for the effective dates of requirement for premarket 
approval.


[[Page 34420]]


    Dated: April 23, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-12041 Filed 5-13-02; 8:45 am]
BILLING CODE 4160-01-S