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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 060 Date of Entry 05/29/2023 
FR Recognition Number 4-302
Standard
ISO  10477 Fourth edition 2020-10
Dentistry - Polymer-based crown and veneering materials
Identical Adoption
ANSI ADA Standard No. 53-2022
Polymer-Based Crown and Veneering Materials
Scope/Abstract
This document specifies requirements and test methods for polymer-based crown and veneering materials used in dentistry. This document applies to polymer-based crown and veneering materials for laboratory-fabricated permanent veneers or crowns. It also applies to polymer-based dental crown and veneering materials for which the manufacturer claims adhesion to the substructure without macro-mechanical retention such as beads or wires.
Extent of Recognition
Complete standard
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.
Transition Period
FDA recognition of ISO 10477 Third edition 2018-06 [Rec# 4-248] will be superseded by recognition of ISO 10477 Fourth edition 2020-10 [Rec# 4-302]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-248] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 4-248] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.3690 Material, Tooth Shade, Resin Class 2 EBF
§872.3770 Crown And Bridge, Temporary, Resin Class 2 EBG
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff - Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions, issued October 2005.

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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