K254109
- 510(k) number
- K254109
- Device name
- G-CEM UNIVERSAL
- Applicant
- GC America, Inc. IL · US
- Product code
- EMA — Cement, Dental
- Decision date
- 2026-05-18
- Date received
- 2025-12-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K254109.pdf
Official FDA record: K254109
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.