Prosthetic devices · 21 CFR 872 Subpart D
Subperiosteal Implant
FDA device type “Implant, Subperiosteal”.
- Companies listing it
- 22 makers
- Brands and models
- 0
- 510(k) clearances
- 41 in five years
- FDA name
- Implant, Subperiosteal
510(k) clearances per year, 1976–2026
Companies that list ELE
2 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| KLS Martin SE & Co. KG | Germany | Maker | — | 43 | 2026 |
| KLS Martin Manufacturing, LLC | United States | Maker | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 8 Jul 2022 | K210228 | KLS Martin IPS Preprosthetic | KLS Martin SE & Co. KG |
| 29 Aug 1986 | K862926 | SURGICAL VITEX | Jeneric Ind. |
| 30 Nov 1984 | K843557 | K-APATITE 20-40 MESH K-APATITE 40-60 | Katecho, Inc. |
| 28 May 1980 | K801208 | HOLLOW BASKET TITANIUM DENTAL IMPLANT | Colmed, Ltd. |
Official records: FDA product classification for ELE · 21 CFR 872.3645.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026