NEI
7 FDA 510(k) clearances · Product code
238 daysmedian time to decision
878 days90th percentile
7clearances measured
FDA profile
- Official device name
- Prosthesis, Condyle, Mandibular, Temporary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.4770
- Medical specialty
- Dental
- Flags
- Implant
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| STRYKER TEMPORARY CONDYLAR PROSTHESIS (K133285) | Stryker | 2014-04-09 |
| MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM (K081747) | Synthes (Usa) | 2008-09-05 |
| SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM (K063181) | Synthes (Usa) | 2007-01-05 |
| OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM (K031701) | Osteomed LP | 2004-07-08 |
| ADD-ON CONDYLE (K002790) | Walter Lorenz Surgical, Inc. | 2001-08-06 |
| KLS-MARTIN TEMPORARY CONDYLAR IMPLANT (K990667) | KLS-Martin L.P. | 2001-07-27 |
| SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD (K990637) | Synthes (Usa) | 1999-10-22 |
Track NEI automatically
Every clearance here is in the API, with alerts when new ones post.