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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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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recognition of ISO 17730 First edition 2014-11 [Rec# 4-257], and ANSI ADA Standard No. 117-2018 [Rec# 4-280] will be superseded by recognition of ISO 17730 Second edition 2020-09 [Rec# 4-319].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
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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