Implant, Subperiosteal
FDA product code ELE · Class II (moderate risk) · 21 CFR 872.3645 · Dental
4510(k) clearances
0PMA approvals
0recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210228 | KLS Martin IPS PreprostheticELE · Traditional | KLS-Martin L.P. | 07/08/2022SE |
| K862926 | Surgical VitexELE · Traditional | Jeneric Ind. | 08/29/1986SE |
| K843557 | K-Apatite 20-40 Mesh K-Apatite 40-60ELE · Traditional | Katecho, Inc. | 11/30/1984SE |
| K801208 | Hollow Basket Titanium Dental ImplantELE · Traditional | Colmed, Ltd. | 05/28/1980SE |