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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Recognition 01/14/2019 
FR Recognition Number 4-253
Standard
ANSI ADA Standard No. 27-2016
Polymer-based Restorative Materials
Scope/Abstract
This Standard specifies requirements for dental polymer-based restorative materials supplied in a form suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation, and intended for use primarily for the direct or indirect restoration of cavities in the teeth and for luting. The polymer-based luting materials covered by this Standard are intended for use in the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and fixed partial prostheses. This Standard does not cover those polymer-based luting materials that have an adhesive component within the structure of the material. This Standard does not cover materials intended to prevent caries (see ISO 6874) or those used for veneering metal sub-frames (see ISO 10477).
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
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
 Wojtek Tutak
  FDA/OMPT/CDRH/ODE/DAGID/DEDB
  301-796-1902
  Wojtek.Tutak@fda.hhs.gov
 Bobak Shirmohammadi
  FDA/OMPT/CDRH/ODE/DAGID/DEDB
  301-796-3639
  Bobak.Shirmohammadi@fda.hhs.gov
 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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