| ANSI ADA Specification No. 38 2000 (R2015) Metal-Ceramic Dental Restorative Systems |
| Recognition Date | 2016-06-27 |
| Recognition List | 043 |
| Recognition Number | 4-86 |
| Extent | Complete standard |
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| 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 standard specifies requirements and test methods for dental metallic materials processed by casting or machining, and for ceramics suitable for use in the fabrication of metal-ceramic dental restorations, together with requirements and test methods for the composite structure. The requirements of this standard apply to the metallic materials and ceramics when used in combination, and compliance may not be claimed for either metallic materials or for ceramics alone.
| 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 |
| §872.3640 | Implant, Endosseous, Root-Form | Class 2 | DZE |
| §872.3060 | Alloy, Gold-Based Noble Metal | Class 2 | EJT |
| §872.3060 | Alloy, Other Noble Metal | Class 2 | EJS |
| There is no relevant guidance developed at this time. |