K251283
- 510(k) number
- K251283
- Device name
- Once-Fil Flow
- Applicant
- Mediclus Co., Ltd. KR
- Product code
- EBF — Material, Tooth Shade, Resin
- Decision date
- 2025-06-06
- Date received
- 2025-04-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K251283.pdf
Official FDA record: K251283
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.