Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

061

Date of Entry 12/18/2023

FR Recognition Number

4-319

Standard

ISO 17730 Second edition 2020-09
Dentistry - Fluoride varnishes

Identical Adoption

ANSI ADA Standard No. 117-2022
Dentistry - Fluoride Varnishes

Scope/Abstract

This document specifies requirements and test methods for total digestible fluoride content and a minimum soluble fluoride release potential in dental varnishes containing fluoride, intended for use in the oral cavity directly on the outer surfaces of teeth and fillings. It also specifies packaging and labelling requirements, including the instructions for use. This document 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."

- Subclause 3.1 fluoride varnish

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." includes prevention of caries that is considered a drug mechanism of action claim under CDER's regulations purview (21 CFR Parts 355) and therefore is not appropriate for a medical device mechanism of action under CDRH's regulations (21 CFR 872.3260).

- Subclause 3.1 includes prevention of caries that is considered a drug mechanism of action claim under CDER's regulations purview (21 CFR Parts 355) and therefore is not appropriate for a medical device mechanism of action under CDRH's regulations (21 CFR 872.3260).

Intended use of caries prevention is in conflict with intended use of the devices in 21 CFR 872.3260 (see product code listed below). Therefore the excepted clauses do not satisfy a premarket requirement under the FD&C Act for caries prevention.

Transition Period

FDA recognition of ISO 17730 First edition 2014-11 [Rec# 4-257], and ANSI ADA Standard No. 117-2018 [Rec# 4-280] will be superseded by recognition of ISO 17730 Second edition 2020-09 [Rec# 4-319]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-257] and [Rec# 4-280] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 4-257] and [Rec# 4-280] will not be accepted.

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
§872.3260	Varnish, Cavity	Class 2	LBH

Relevant FDA Guidance and/or Supportive Publications*

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.

FDA Technical Contacts

Michael Adjodha

FDA/OC/CDRH/OPEQ/OHTI/DHTIB/

301-796-6276

michael.adjodha@fda.hhs.gov

Joel Anderson

FDA/OC/CDRH/OPEQ/OHTI/DHTIB/

301-796-6520

joel.anderson@fda.hhs.gov

Ran Huo

FDA/OMPT/CDRH/OPEQ/OHT1/DHT1B

ran.huo@fda.hhs.gov