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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Entry 01/14/2019 
FR Recognition Number 4-256
Standard
ANSI ADA Standard No. 132-2015
Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems
Scope/Abstract
This standard describes test methods used to evaluate the repeatability, reproducibility and accuracy of dental devices for 3D metrology. The standard is applicable to dental chairside and dental laboratory CAD/CAM systems. The scope of this document is not intended to include unique systems with other specific applications of 3D metrology in the dental field such as 3D computed tomography, magnetic resonance imaging and stereophotogrammetry.
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
§872.3661 Scanner, Color Class 2 KZN
§872.3661 System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations Class 2 NOF
Relevant FDA Guidance and/or Supportive Publications*
Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA, Issued April 22, 2003.
FDA Technical Contacts
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  michael.adjodha@fda.hhs.gov
 Joel Anderson
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6520
  joel.anderson@fda.hhs.gov
 Andrew Steen
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6284
  Andrew.Steen@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
*These are provided as examples and others may be applicable.
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