| ISO 22674 Second edition 2016-01-15 Dentistry - Metallic materials for fixed and removable restorations and appliances |
| Recognition Date | 2016-06-27 |
| Recognition List | 043 |
| Recognition Number | 4-227 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Dental/ENT |
| FDA Tech | Michael Adjodha FDA/OMPT/CDRH/ODE/DAGID/DEDB 301-796-6276 michael.adjodha@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This International Standard classifies metallic materials that are suitable for the fabrication of dental restorations and appliances, including metallic materials recommended for use either with or without a ceramic veneer, or recommended for both uses, and specifies their requirements. Furthermore, it specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for the use of these materials, including products delivered for sale to a third party.
This International Standard does not apply to alloys for dental amalgam (ISO 24234), dental brazing materials (ISO 9333), or metallic materials for orthodontic appliances (ISO 15841) (e.g. wires, brackets, bands and screws).
| Regulation Number | Device Name | Device Class | Product Code |
| §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 |
| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Noble Mental 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 |