K233158
- 510(k) number
- K233158
- Device name
- Copra Smile, Copra Supreme Hyperion
- Applicant
- Whitepeaks Dental Solutions GmbH DE
- Product code
- EIH — Powder, Porcelain
- Decision date
- 2024-06-20
- Date received
- 2023-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K233158.pdf
Official FDA record: K233158
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.