BracePaste Prime Plus
Device Facts
| Record ID | K261840 |
|---|---|
| Device Name | BracePaste Prime Plus |
| Applicant | American Orthodontics |
| Product Code | DYH · Dental |
| Decision Date | Jun 3, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3750 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
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.
