OIV
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dental Amalgam
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3070
- Medical specialty
- Dental
- Flags
- Third-party review eligible
- FDA definition
- Dental amalgam is a device that consists of a metallic alloy, such as silver, tin, copper, and zinc, that is mixed with liquid elemental mercury for the direct filling of carious lesions or structural defects in teeth
- Adverse events (MAUDE)
- 2008: 10
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy (K223182) | Worldwork S.R.L | 2023-05-01 |
| NEW STETIC DENTAL AMALGAM ALLOY (K140125) | New Stetic | 2014-04-29 |
| ULTRACAPS S (K081273) | Sdi , Ltd. | 2008-07-10 |
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Every clearance here is in the API, with alerts when new ones post.