JAZ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Prosthesis, Facial, Mandibular Implant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3695
- Medical specialty
- Ear, Nose, Throat
- Flags
- Implant
- Adverse events (MAUDE)
- 2000: 1 · 2005: 13 · 2006: 10 · 2007: 8 · 2008: 4 · 2009: 7
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 |
|---|---|---|
| INVOTEC POLY-MESH MANDIBULAR TRAY (K901923) | Invotec International, Inc. | 1990-10-31 |
| XOMED MANDIBULAR TRAY (K821904) | Xomed, Inc. | 1982-07-26 |
Track JAZ automatically
Every clearance here is in the API, with alerts when new ones post.