ISO 9693-1 First edition 2012-02-15

Standard Organization:

ISO 9693-1 First edition 2012-02-15
Dentistry -- Compatibility testing - Part 1: Metal-ceramic systems

Recognition Date2014-01-30
Recognition List034
Recognition Number4-201
Extent Complete standard
Standards Orgs ISO International Organization for Standardization https://www.iso.org/
STG Dental/ENT
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Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

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.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§872.6660 Powder, Porcelain Class 2 EIH
§872.3920 Teeth, Porcelain Class 2 ELL
§872.3710 Alloy, Metal, Base Class 2 EJH
§872.3060 Alloy, Gold-Based Noble Metal Class 2 EJT
§872.3060 Alloy, Other Noble Metal Class 2 EJS

FDA Guidance:

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

Guidance for Industry and FDA Staff Class II Special Controls Guidance Document:
Dental Base Metal Alloys Document issued on: 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 on: May 12, 2004

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