ORTHODONTIC BONDING ADHESIVE CONTROL
Device Facts
| Record ID | K904090 |
|---|---|
| Device Name | ORTHODONTIC BONDING ADHESIVE CONTROL |
| Applicant | Lancer Orthodontics, Inc. |
| Product Code | DYH · Dental |
| Decision Date | Apr 29, 1991 |
| 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.