ORMCO TRANSMANDIBULAR IMPLANT
Device Facts
| Record ID | K852894 |
|---|---|
| Device Name | ORMCO TRANSMANDIBULAR IMPLANT |
| Applicant | Ormco Corp. |
| Product Code | MDL · Dental |
| Decision Date | Aug 29, 1985 |
| Decision | SESP |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4760 |
| Device Class | Class 2 |
Regulatory Classification
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.
