Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

051

Date of Entry 01/14/2019 

FR Recognition Number

4-255

Standard

ANSI ADA  Standard No. 131-2015 (R2020)
Dental CAD/CAM Machinable Zirconia Blanks

Scope/Abstract

This standard specifies the requirements and test methods for partially stabilized zirconia materials used for the fabrication of dental fixed restorations.

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
§872.3920	Teeth, Porcelain	Class 2	ELL
§872.6660	Powder, Porcelain	Class 2	EIH

Relevant FDA Guidance and/or Supportive Publications*

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.