| ISO 10271 Second edition 2011-08-01 Dentistry - Corrosion test methods for metallic materials |
| Recognition Number | Dental/ENT |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 4-245 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Dental/ENT |
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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 provides test methods and procedures to determine the corrosion behavior of metallic materials used in the oral cavity. It is intended that the test methods and procedures in this International Standard be referred to in the individual International Standards specifying such metallic materials.
This International Standard is not applicable to instruments and dental amalgam and appliances for orthodontics.
| 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 |
| Class II Special Controls Guidance Document: Dental Noble Metal Alloys - Guidance for Industry and FDA Staff, Issued August 2004. Class II Special Controls Guidance Document: Dental Base Metal Alloys - Guidance for Industry and FDA Staff, Issued August 2004. |