K233152
- 510(k) number
- K233152
- Device name
- GENIOVA aligners
- Applicant
- Geniova Technologies Sociedad Limitada ES
- Product code
- NXC — Aligner, Sequential
- Decision date
- 2024-12-12
- Date received
- 2023-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K233152.pdf
Official FDA record: K233152
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.