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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Recognition 01/30/2014 
FR Recognition Number 4-126
Standard
ISO 10477 Second edition 2004-10-01
Dentistry - Polymer-based crown and bridge materials
Scope/Abstract
ISO 10477:2004 classifies polymer-based dental crown and bridge materials and specifies their requirements. It also specifies the test methods to be used to determine compliance with these requirements.

ISO 10477:2004 is applicable to polymer-based dental crown and bridge materials for laboratory-fabricated permanent facings or anterior crowns that may or may not be attached to a metal substructure. It also applies to polymer-based dental crown and bridge materials for which the manufacturer claims adhesion to the metal substructure without macromechanical retention such as beads or wires.

ISO 10477:2004 is not applicable to polymer-based materials that are used to make crowns, veneers or repairs in the operatory, nor does it cover the application of those materials to stress-bearing areas of posterior teeth.

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FDA recognition of ISO 10477 Second edition 2004-10-01 [Rec# 4-126] will be superseded by recognition of ISO 10477 Third edition 2018-06 [Rec# 4-248].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 Contact
 Andrew Steen
  FDA/OMPT/CDRH/ODE/DAGID/DEDB/
  301-796-6284
  andrew.steen@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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