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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 4-280
Standard
ANSI ADA Standard No. 117-2018
Fluoride varnishes
Scope/Abstract
This standard specifies requirements and their test methods for total digestible fluoride content in dental varnishes containing fluoride, intended for use in the oral cavity directly on the outer surfaces of teeth and fillings. It also specifies the requirements for their packaging and labelling, including the instructions for use. This standard covers fluoride varnishes to be applied by dental health care workers.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Introduction, the sentence, "Fluoride varnishes are used in dentistry primarily for caries prevention"
Includes prevention of caries that is considered a drug mechanism of action claim under CDER's regulations purview (21 CFR Parts 355) and is not considered appropriate for a medical device mechanism of action under CDRH's regulations (§872.3260).

Definition "3.2 fluoride varnish"
Includes prevention of caries that is considered a drug mechanism of action claim under CDER's regulations purview (21 CFR Parts 355) and is not considered appropriate for a medical device mechanism of action under CDRH's regulations (§872.3260).
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

This standard is recognized in part because:

Introduction, the sentence, "Fluoride varnishes are used in dentistry primarily for caries prevention" is in conflict with an existing regulation, 21 CFR Parts 355 under the jurisdiction of CDER.

Definition "3.2 fluoride varnish" is in conflict with an existing regulation, 21 CFR Parts 355 under the jurisdiction of CDER.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.3260 Varnish, Cavity Class 2 LBH
FDA Technical Contacts
 Michelle Chavis
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  --
  Michelle.Chavis@fda.hhs.gov
 Joel Anderson
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6520
  joel.anderson@fda.hhs.gov
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  michael.adjodha@fda.hhs.gov
Standards Development Organizations
ADA American Dental Association http://www.ada.org
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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