K250763
- 510(k) number
- K250763
- Device name
- Reon
- Applicant
- C.E.I.B.Med KR
- Product code
- EBF — Material, Tooth Shade, Resin
- Decision date
- 2025-05-12
- Date received
- 2025-03-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K250763.pdf
Official FDA record: K250763
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.