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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 055 Date of Entry 12/21/2020 
FR Recognition Number 4-270
Standard
ANSI ADA  Technical Report No. 146-2018
CAD/CAM Abutments in Dentistry
Scope/Abstract
CAD/CAM abutments have an anatomically correct emergence profile and restoration substructure specific to the patient (i.e. patient specific). This technical report provides references for test methods that can be used for assessing reliability, accuracy and reproducibility of patient specific CAD/CAM abutments designed for use with a manufacturer's own implants or for use with implants from other manufacturers; as well as guidelines for standardization of future products. The abutment is individually designed by a laboratory or doctor to be attached to an implant by means of an abutment screw, dental cement or friction fit. This document provides on abutments where milling is done at a central milling facility, a dental lab, or by an in-office milling machine.
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
§872.3630 Abutment, Implant, Dental, Endosseous Class 2 NHA
§872.3630 Dental Abutment Design Software For Dental Laboratory Class 2 PNP
§872.3640 Implant, Endosseous, Root-Form Class 2 DZE
§872.3640 Blade-Form Endosseous Dental Implant Class 2 NRQ
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, issued May 2004.

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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