K252808
- 510(k) number
- K252808
- Device name
- GlasIonomer FX-LC
- Applicant
- Shofu Dental Corporation CA · US
- Product code
- EMA — Cement, Dental
- Decision date
- 2025-12-09
- Date received
- 2025-09-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K252808
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.