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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 054 Date of Entry 07/06/2020 
FR Recognition Number 4-263
Standard
ISO 9693 Third edition 2019-10 Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems
Scope/Abstract
This document specifies requirements and test methods to assess the thermomechanical compatibility between a veneering ceramic and a metallic or ceramic substructure material used for dental restorations.

This document applies only to the materials used in combination. Conformity cannot be claimed for a single material.

For requirements for ceramic materials, see ISO 6872. For requirements for metallic materials see ISO 22674.
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FDA recognition of ISO 9693-1 First edition 2012-02-15 [Rec# 4-201] will be superseded by recognition of ISO 9693 Third edition 2019-10 [Rec# 4-263].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*
1. Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Dental Noble Metal Alloys, issued August 23, 2004.

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

3. ISO 6872 Dentistry - Ceramic materials.

4. ISO 22674 Dentistry - Metallic materials for fixed and removable restorations and appliances.
FDA Technical Contacts
 Michelle Chavis
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  --
  Michelle.Chavis@fda.hhs.gov
 Joel Anderson
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6520
  joel.anderson@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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