Cleared Traditional

G aenial Universal Injectable II

K251946 · GC America, Inc. · Dental
Aug 2025
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K251946 is an FDA 510(k) clearance for the G aenial Universal Injectable II, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on August 29, 2025, 65 days after receiving the submission on June 25, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K251946 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 2025
Decision Date August 29, 2025
Days to Decision 65 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690