GC MODELS OPA-100 AND JC-50
Device Facts
| Record ID | K073588 |
|---|---|
| Device Name | GC MODELS OPA-100 AND JC-50 |
| Applicant | GC America, Inc. |
| Product Code | DYH · Dental |
| Decision Date | Feb 15, 2008 |
| 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.
