OrthoFit
Device Facts
| Record ID | K261129 |
|---|---|
| Device Name | OrthoFit |
| Applicant | Spident Co., Ltd. |
| Product Code | DYH · Dental |
| Decision Date | Jul 2, 2026 |
| 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.
