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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Recognition 01/14/2019 
FR Recognition Number 4-248
Standard
ISO 10477 Third edition 2018-06
Dentistry - Polymer-based crown and veneering materials
Scope/Abstract
This document classifies polymer-based crown and veneering materials used in dentistry and specifies their requirements. It also specifies the test methods to be used to determine conformity to these requirements.

This document is applicable 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FDA recognition of ISO 10477 Second edition 2004-10-01 [Rec# 4-126] will be superseded by recognition of ISO 10477 Third edition 2018-06 [Rec# 4-248]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-126] until December 28, 2019. After this transition period, declarations of conformity to [Rec# 4-126] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§872.3770 Crown And Bridge, Temporary, Resin Class 2 EBG
§872.3690 Material, Tooth Shade, Resin Class 2 EBF
Relevant FDA Guidance and/or Supportive Publications
Guidance for Industry and FDA Staff: Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions, Issued October 26, 2005.
FDA Technical Contacts
 Michael Adjodha
  FDA/OMPT/CDRH/ODE/DAGID/DEDB
  301-796-6276
  michael.adjodha@fda.hhs.gov
 Joel Anderson
  FDA/OMPT/CDRH/ODE/DAGID/DEDB/
  301-796-6520
  joel.anderson@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Dental/ENT
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