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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 049 Date of Recognition 06/07/2018 
FR Recognition Number 4-241
Standard
ISO 7491 Second edition 2000-09-01
Dental materials - Determination of colour stability
U.S. Identical Adoption
ANSI ADA Specification No.80 2001 (Reaffirmed 2013)
Dental Materials - Determination of Color Stability
Scope/Abstract
This International Standard specifies a method for the determination of the colour stability of dental materials after exposure to light and water.
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.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§872.3920 Teeth, Porcelain Class 2 ELL
§872.3910 Teeth, Artificial, Backing And Facing Class 1 ELK
§872.3900 Teeth, Artificial, Posterior With Metal Insert Class 1 ELJ
§872.3770 Crown And Bridge, Temporary, Resin Class 2 EBG
§872.3760 Resin, Denture, Relining, Repairing, Rebasing Class 2 EBI
§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 2005.
FDA Technical Contact
 Michael Adjodha
  FDA/OMPT/CDRH/ODE/DAGID/DEDB
  301-796-6276
  michael.adjodha@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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