G aenial Universal Injectable II— 510(k) K251946

Substantially Equivalent

GC America, Inc.

FDA 510(k) clearance K251946 for G aenial Universal Injectable II, Substantially Equivalent on 2025-08-29. Applicant: GC America, Inc..

Clearance details

Applicant: GC America, Inc.
Product code: Code EBF
Advisory panel: Dental
Date received: 2025-06-25
Decision date: 2025-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alsip, IL, US

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