SureSmile Aligner (ASSY500020)
Device Facts
| Record ID | K260722 |
|---|---|
| Device Name | SureSmile Aligner (ASSY500020) |
| Applicant | Dentsply Sirona, Inc. |
| Product Code | NXC · Dental |
| Decision Date | Apr 15, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.5470 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.
