ELE
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Implant, Subperiosteal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3645
- Medical specialty
- Dental
- Flags
- Implant
- Adverse events (MAUDE)
- 1997: 1
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 |
|---|---|---|
| KLS Martin IPS Preprosthetic (K210228) | KLS-Martin L.P. | 2022-07-08 |
| SURGICAL VITEX (K862926) | Jeneric Ind. | 1986-08-29 |
| K-APATITE 20-40 MESH K-APATITE 40-60 (K843557) | Katecho, Inc. | 1984-11-30 |
| HOLLOW BASKET TITANIUM DENTAL IMPLANT (K801208) | Colmed, Ltd. | 1980-05-28 |
Track ELE automatically
Every clearance here is in the API, with alerts when new ones post.