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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 4-89
Standard
ANSI ADA Standard No. 53 - 2008 (Reaffirmed 2013)
Polymer-Based Crown and Bridge Materials
Scope/Abstract
This standard 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. This standard 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.
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
§872.3770 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 2005.
FDA Technical Contact
 Michael Adjodha
  FDA/OMPT/CDRH/ODE/DAGID/DEDB
  301-796-6276
  michael.adjodha@fda.hhs.gov
Standards Development Organizations
ADA American Dental Association http://www.ada.org
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Dental/ENT
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