MDL
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Implant, Transmandibular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.4760
- Medical specialty
- Dental
- Flags
- Implant
- Adverse events (MAUDE)
- 1994: 3
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 |
|---|---|---|
| SMOOTH STAPLE IMPLANT (K900433) | Interphase Implants, Inc. | 1990-11-16 |
| ORMCO TRANSMANDIBULAR IMPLANT (K852894) | Ormco Corp. | 1985-08-29 |
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Every clearance here is in the API, with alerts when new ones post.