K233502
- 510(k) number
- K233502
- Device name
- TERA HARZ II
- Applicant
- Graphy, Inc. KR
- Product code
- EBF — Material, Tooth Shade, Resin
- Decision date
- 2023-11-01
- Date received
- 2023-10-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K233502.pdf
Official FDA record: K233502
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.