MDL · Implant, Transmandibular
Dental · 21 CFR 872.4760 · Class 2
Overview
| Product Code | MDL |
|---|---|
| Device Name | Implant, Transmandibular |
| Regulation | 21 CFR 872.4760 |
| Device Class | Class 2 |
| Review Panel | Dental |
| Implant | Yes |
Identification
A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.
Classification Rationale
Class II.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K900433 | SMOOTH STAPLE IMPLANT | Interphase Implants, Inc. | Nov 16, 1990 | SESP |
| K852894 | ORMCO TRANSMANDIBULAR IMPLANT | Ormco Corp. | Aug 29, 1985 | SESP |
Top Applicants
- Ormco Corp. — 1 clearance
- Interphase Implants, Inc. — 1 clearance
