[Federal Register Volume 89, Number 134 (Friday, July 12, 2024)]
[Notices]
[Pages 57155-57157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15337]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2024-D-2511 and FDA-2024-D-2512]


Dental Composite Resin Devices and Dental Curing Lights--
Premarket Notification (510(k)) Submissions Guidances; Draft Guidances 
for Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of two draft guidances entitled ``Dental Composite 
Resin Devices--Premarket Notification (510(k)) Submissions'' and 
``Dental Curing Lights--Premarket Notification (510(k)) Submissions.'' 
These draft guidance documents provide recommendations for device 
description, performance testing, and labeling to include in 510(k) 
submissions for dental composite resin devices and dental curing 
lights. When final, these guidances will supersede the guidances 
``Dental Composite Resin Devices--Premarket Notification [510(k)] 
Submissions'' dated October 26, 2005 and ``Dental Curing Lights--
Premarket Notification [510(k)] Submissions'' dated March 27, 2006. The 
recommendations in these draft guidances are intended to promote 
consistency and facilitate efficient review of these submissions. These 
draft guidances are not final nor are they for implementation at this 
time.

[[Page 57156]]


DATES: Submit either electronic or written comments on the draft 
guidance by September 10, 2024 to ensure that the Agency considers your 
comment on the draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2024-D-2511 for ``Dental Composite Resin Devices--Premarket 
Notification (510(k)) Submissions'' or the Docket No. FDA-2024-D-2512 
for ``Dental Curing Lights--Premarket Notification (510(k)) 
Submissions.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    An electronic copy of the guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``Dental Composite Resin Devices--Premarket Notification (510(k)) 
Submissions'' or ``Dental Curing Lights--Premarket Notification 
(510(k)) Submissions'' to the Office of Policy, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request.

FOR FURTHER INFORMATION CONTACT: Michael Adjodha, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. G304, Silver Spring, MD 20993-0002, 301-
796-6276.

SUPPLEMENTARY INFORMATION:

I. Background

    These draft guidance documents provide recommendations for device 
description, performance testing, and labeling to include in 510(k) 
submissions for dental composite resin devices and dental curing 
lights. Dental composite resin devices are devices intended to fill and 
restore defects or carious lesions in teeth. The device may be supplied 
as a two-part base and catalyst system that is self-cured or a one-part 
system that is cured via photoinitiation. Dental curing lights are 
devices that emit non-ionizing optical radiation intended to 
photopolymerize dental restorative resins. These guidances, when final, 
will supersede ``Dental Composite Resin Devices--Premarket Notification 
[510(k)] Submissions'' dated October 26, 2005 and ``Dental Curing 
Lights--Premarket Notification [510(k)] Submissions'' dated March 27, 
2006. The recommendations in these draft guidances are intended to 
promote consistency and facilitate efficient review of these 
submissions.
    These draft guidances are being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). These draft guidances, 
when finalized, will represent the current thinking of FDA on Dental 
Composite Resin Devices--Premarket Notification (510(k)) Submissions 
and Dental Curing Lights--Premarket Notification (510(k)) Submissions. 
They do not establish any rights for any person and are not binding on 
FDA or the public. You can use an alternative approach if it satisfies 
the requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons interested in obtaining copies of the draft guidances may 
do so by downloading an electronic copy from the internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. These guidance documents are 
also available at https://www.regulations.gov and

[[Page 57157]]

https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to download an electronic copy of ``Dental 
Composite Resin Devices--Premarket Notification (510(k)) Submissions 
(document number GUI00016050)'' or ``Dental Curing Lights--Premarket 
Notification (510(k)) Submissions (document number GUI00016017)'' may 
send an email request to [email protected] to receive an 
electronic copy of the document. Please use the document number and 
complete title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While these guidances contain no new collection of information, 
they do refer to previously approved FDA collections of information. 
The previously approved collections of information are subject to 
review by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of 
information in the following table have been approved by OMB:

------------------------------------------------------------------------
                                                            OMB control
    21 CFR part or guidance               Topic                 No.
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807, subpart E.................  Premarket notification.       0910-0120
812............................  Investigational Device        0910-0078
                                  Exemption.
``Requests for Feedback and      Q-submissions and Early       0910-0756
 Meetings for Medical Device      Payor Feedback Request
 Submissions: The Q-Submission    Programs for Medical
 Program''.                       Devices.
800, 801, 809, and 830.........  Medical Device Labeling       0910-0485
                                  Regulations; Unique
                                  Device Identification.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
50, 56.........................  Protection of Human           0910-0130
                                  Subjects and
                                  Institutional Review
                                  Boards.
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    Dated: July 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15337 Filed 7-11-24; 8:45 am]
BILLING CODE 4164-01-P