K251616
- 510(k) number
- K251616
- Device name
- Clear Miracle
- Applicant
- Ods Co., Ltd. KR
- Product code
- NXC — Aligner, Sequential
- Decision date
- 2025-07-22
- Date received
- 2025-05-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K251616.pdf
Official FDA record: K251616
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.