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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 4-201
Standard
ISO 9693-1 First edition 2012-02-15 Dentistry -- Compatibility testing - Part 1: Metal-ceramic systems
Scope/Abstract
This part of ISO 9693 specifies test methods for determining the compatibility of metallic and ceramic materials used for dental restorations by testing the composite structure.

The requirements given in this part of ISO 9693 are applicable to metallic materials and ceramics when used in combination, and are not applicable to either metallic materials or ceramics when used alone.

NOTE Requirements for metallic materials are given in ISO 22674; requirements for ceramic materials are given in ISO 6872.
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.
Transition Period
FDA recognition of ISO 9693-1 First edition 2012-02-15 [Rec# 4-201] will be superseded by recognition of ISO 9693 Third edition 2019-10 [Rec# 4-263]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-201] until July 11, 2021. After this transition period, declarations of conformity to [Rec# 4-201] will not be accepted.
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
§872.3710 Alloy, Metal, Base Class 2 EJH
§872.3920 Teeth, Porcelain Class 2 ELL
§872.6660 Powder, Porcelain Class 2 EIH
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Dental Noble Metal Alloys, issued August 23, 2004.

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Dental Base Metal Alloys, issued August 23, 2004.

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments Document issued May 12, 2004.
FDA Technical Contacts
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  michael.adjodha@fda.hhs.gov
 Andrew Steen
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6284
  andrew.steen@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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