Surgical devices · 21 CFR 872 Subpart E
Transmandibular Implant
FDA device type “Implant, Transmandibular”.
- Companies listing it
- 00 makers
- Brands and models
- 0
- 510(k) clearances
- 20 in five years
- FDA name
- Implant, Transmandibular
510(k) clearances per year, 1976–2026
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 16 Nov 1990 | K900433 | SMOOTH STAPLE IMPLANT | Interphase Implants, Inc. |
| 29 Aug 1985 | K852894 | ORMCO TRANSMANDIBULAR IMPLANT | Sybron Dental Specialties |
Official records: FDA product classification for MDL · 21 CFR 872.4760.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026