FACE4D Aligner
Device Facts
| Record ID | K260527 |
|---|---|
| Device Name | FACE4D Aligner |
| Applicant | Avinent Implant System S.L.U. |
| Product Code | NXC · Dental |
| Decision Date | Jul 2, 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.
