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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 049 Date of Entry 06/07/2018 
FR Recognition Number 4-241
ISO  7491 Second edition 2000-09-01
Dental materials - Determination of colour stability
Identical Adoption
ANSI ADA Standard No. 80-2001 (R2020)
Dental Materials-Determination of Color Stability
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
§872.3690 Material, Tooth Shade, Resin Class 2 EBF
§872.3760 Denture relining, repairing, or rebasing resin. Resin, Denture, Relining, Repairing, Rebasing Class 2 EBI
§872.3770 Crown And Bridge, Temporary, Resin Class 2 EBG
§872.3900 Teeth, Artificial, Posterior With Metal Insert Class 1 ELJ
§872.3910 Teeth, Artificial, Backing And Facing Class 1 ELK
§872.3920 Teeth, Porcelain Class 2 ELL
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 Contact
 Michael Adjodha
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.