CHALLENGE ORTHODONTIC BONDING ADHESIVE
Device Facts
| Record ID | K863709 |
|---|---|
| Device Name | CHALLENGE ORTHODONTIC BONDING ADHESIVE |
| Applicant | Ormco Corp. |
| Product Code | DYH · Dental |
| Decision Date | Jan 21, 1987 |
| 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.
