K240597
- 510(k) number
- K240597
- Device name
- TERA HARZ CLEAR
- Applicant
- Graphy, Inc. KR
- Product code
- NXC — Aligner, Sequential
- Decision date
- 2024-03-05
- Date received
- 2024-03-04
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Flag
- Third-party review
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K240597.pdf
Official FDA record: K240597
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.