K260527
- 510(k) number
- K260527
- Device name
- FACE4D Aligner
- Applicant
- Avinent Implant System S.L.U. ES
- Product code
- NXC — Aligner, Sequential
- Decision date
- 2026-07-02
- Date received
- 2026-02-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K260527.pdf
Official FDA record: K260527
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.