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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 064 Date of Entry 05/26/2025 
FR Recognition Number 4-344
Standard
ANSI ADA  Standard No. 186-2024
Dentistry - Polymer-based Machinable Blanks
Scope/Abstract
This standard specifies the characteristics of polymer-based machinable blanks with respect to the milling process and provides the test methods that address the clinical issues specific to those materials.
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
§872.3770 Crown And Bridge, Temporary, Resin Class 2 EBG
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 Contacts
 Andrew Steen
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6284
  Andrew.Steen@fda.hhs.gov
 Joel Anderson
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6520
  Joel.Anderson@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
ADA American Dental Association http://www.ada.org
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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