BRACKET BONDING SYSTEM METAL & PLASTIC
Device Facts
| Record ID | K800392 |
|---|---|
| Device Name | BRACKET BONDING SYSTEM METAL & PLASTIC |
| Applicant | American Dental Research |
| Product Code | DYH · Dental |
| Decision Date | Apr 10, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3750 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.