TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT
Device Facts
| Record ID | K950514 |
|---|---|
| Device Name | TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT |
| Applicant | 3M Unitek |
| Product Code | DYH · Dental |
| Decision Date | Mar 7, 1995 |
| 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.
