Prosthetic devices · 21 CFR 872 Subpart D
Dental Amalgam
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
- Companies listing it
- 53 makers
- Brands and models
- 7
- 510(k) clearances
- 31 in five years
- FDA name
- Dental Amalgam
510(k) clearances per year, 1976–2026
Companies that list OIV
5 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Sdi Limited | Australia | Maker | Ultracaps S | 8 | 2022 |
| New Stetic, SA | Colombia | Maker | Micronic · NU Alloy DP · Nu Alloy DP Active | 5 | 2026 |
| Worldwork S.R.L | Italy | Maker | ALLOY, AMALGAM DENTAL AMALGAM | 1 | 2023 |
| Jersey Dental Supplies | United States | Repacker / relabeler | NEW STETIC DENTAL AMALGAM ALLOY | — | — |
| Caribbean Dental Products Corp. | United States | Repacker / relabeler | AMALGAM | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 1 May 2023 | K223182 | 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 | Worldwork S.R.L |
| 29 Apr 2014 | K140125 | NEW STETIC DENTAL AMALGAM ALLOY | New Stetic, SA |
| 10 Jul 2008 | K081273 | ULTRACAPS S | Sdi Limited |
Official records: FDA product classification for OIV · 21 CFR 872.3070.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026