Product code ELE
- Device name
- Implant, Subperiosteal
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.3645
- Review panel
- DE
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K210228 | KLS Martin IPS Preprosthetic | KLS-Martin L.P. | 2022-07-08 |
| K862926 | SURGICAL VITEX | Jeneric Ind. | 1986-08-29 |
| K843557 | K-APATITE 20-40 MESH K-APATITE 40-60 | Katecho, Inc. | 1984-11-30 |
| K801208 | HOLLOW BASKET TITANIUM DENTAL IMPLANT | Colmed, Ltd. | 1980-05-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00888118150646 | IPS | KLS-Martin L.P. | 2026-05-25 |
| 00888118140968 | IPS | KLS-Martin L.P. | 2025-11-26 |
| 00888118148834 | IPS | KLS-Martin L.P. | 2025-11-26 |
| 00888118148827 | IPS | KLS-Martin L.P. | 2025-11-26 |
| 00888118148810 | IPS | KLS-Martin L.P. | 2025-11-26 |
| 00888118148803 | IPS | KLS-Martin L.P. | 2025-11-26 |
| 00888118148797 | IPS | KLS-Martin L.P. | 2025-11-26 |
| 00888118148780 | IPS | KLS-Martin L.P. | 2025-11-26 |
| 00888118148773 | IPS | KLS-Martin L.P. | 2025-11-26 |
| 00888118148759 | IPS | KLS-Martin L.P. | 2025-11-26 |
| 00888118148742 | IPS | KLS-Martin L.P. | 2025-11-26 |
| 00888118141828 | IPS | KLS-Martin L.P. | 2025-11-26 |
| 00888118141811 | IPS | KLS-Martin L.P. | 2025-11-26 |
| 00888118141804 | IPS | KLS-Martin L.P. | 2025-11-26 |
| 00888118140982 | IPS | KLS-Martin L.P. | 2025-11-26 |
| 00888118140975 | IPS | KLS-Martin L.P. | 2025-11-26 |
| 00888118148766 | IPS | KLS-Martin L.P. | 2025-11-26 |
| 00888118145048 | IPS | KLS-Martin L.P. | 2024-11-25 |
| 00888118145079 | IPS | KLS-Martin L.P. | 2024-11-25 |
| 00888118145062 | IPS | KLS-Martin L.P. | 2024-11-25 |
| 00888118145055 | IPS | KLS-Martin L.P. | 2024-11-25 |
| 00888118145031 | IPS | KLS-Martin L.P. | 2024-11-25 |
| 00888118145024 | IPS | KLS-Martin L.P. | 2024-11-25 |
| 00888118141835 | IPS | KLS-Martin L.P. | 2023-08-24 |
| 00888118141842 | IPS | KLS-Martin L.P. | 2023-08-24 |
| 00888118141859 | IPS | KLS-Martin L.P. | 2023-08-24 |
| 00888118141866 | IPS | KLS-Martin L.P. | 2023-08-24 |
| 00888118141873 | IPS | KLS-Martin L.P. | 2023-08-24 |
| 00888118141880 | IPS | KLS-Martin L.P. | 2023-08-24 |
| D001N001230 | Vitallium® | Dentsply International Inc. | 2018-06-30 |