K260788
- 510(k) number
- K260788
- Device name
- Smylio Aligners
- Applicant
- Smylio, Inc. CA · US
- Product code
- NXC — Aligner, Sequential
- Decision date
- 2026-05-08
- Date received
- 2026-03-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K260788
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.