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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 043 Date of Entry 06/27/2016 
FR Recognition Number 4-86
Standard
ANSI ADA Standard No. 38-2000 (R2015) Metal-Ceramic Dental Restorative Systems
Scope/Abstract
This standard specifies requirements and test methods for dental metallic materials processed by casting or machining, and for ceramics suitable for use in the fabrication of metal-ceramic dental restorations, together with requirements and test methods for the composite structure. The requirements of this standard apply to the metallic materials and ceramics when used in combination, and compliance may not be claimed for either metallic materials or for ceramics alone.
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
§872.3060 Alloy, Gold-Based Noble Metal Class 2 EJT
§872.3060 Alloy, Other Noble Metal Class 2 EJS
§872.3640 Implant, Endosseous, Root-Form Class 2 DZE
§872.3710 Alloy, Metal, Base Class 2 EJH
§872.3920 Teeth, Porcelain Class 2 ELL
§872.6660 Powder, Porcelain Class 2 EIH
FDA Technical Contact
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  michael.adjodha@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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