ORMCO SYSTEM 1+ (TM)
Device Facts
| Record ID | K941015 |
|---|---|
| Device Name | ORMCO SYSTEM 1+ (TM) |
| Applicant | Ormco Corp. |
| Product Code | DYH · Dental |
| Decision Date | Mar 31, 1994 |
| 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.
