CERAMAFLEX BRACKET SYSTEM
Device Facts
| Record ID | K950992 |
|---|---|
| Device Name | CERAMAFLEX BRACKET SYSTEM |
| Applicant | Tp Orthodontics, Inc. |
| Product Code | NJM · Dental |
| Decision Date | May 3, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.5470 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.
