G-CEM UNIVERSAL— 510(k) K254109
Substantially EquivalentGC America, Inc.
FDA 510(k) clearance K254109 for G-CEM UNIVERSAL, Substantially Equivalent on 2026-05-18. Applicant: GC America, Inc.. Device class: 2.
Summary
GC America's G-CEM UNIVERSAL is filed under EMA, dental cements.
Class II, 21 CFR 872.3275. Dental is both the classification panel and the review panel, and the submission was a Traditional 510(k).
GC America filed from Alsip, Illinois. Review took 150 calendar days (December 19, 2025 to May 18, 2026).
Clearance details
- Applicant
- GC America, Inc.
- Product code
- Product code EMA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3275
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alsip, IL, US
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