BRACKET, METAL REINFORCED PLASTIC
Device Facts
| Record ID | K780239 |
|---|---|
| Device Name | BRACKET, METAL REINFORCED PLASTIC |
| Applicant | Ormco Corp. |
| Product Code | DYW · Dental |
| Decision Date | Mar 15, 1978 |
| 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.