| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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056
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Date of Entry 06/07/2021
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FR Recognition Number
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4-280
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| Standard | |
ANSI ADA Standard No. 117-2018
Fluoride varnishes |
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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. |
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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). |
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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. |
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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. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §872.3260 |
Varnish, Cavity
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Class 2
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LBH
|
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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. |
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| FDA Technical Contacts
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| Standards Development Organizations
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
