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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 051 Date of Entry 01/14/2019 
FR Recognition Number 4-257
ISO  17730 First edition 2014-11-01
Dentistry - Fluoride varnishes
This International 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 International 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"
-Definition 3.2, 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 it:
Conflicts with an existing regulation. Intended use of caries prevention conflicts with intended use of the device in 21 CFR 872.3260; see Procode listing 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recognition of ISO 17730 First edition 2014-11 [Rec# 4-257], and ANSI ADA Standard No. 117-2018 [Rec# 4-280] will be superseded by recognition of ISO 17730 Second edition 2020-09 [Rec# 4-319].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
 Joel Anderson
 Ran Huo
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.