Cleared Traditional

G-Bond Universal

K251124 · GC America, Inc. · Dental
Oct 2025
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K251124 is an FDA 510(k) clearance for the G-Bond Universal, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on October 2, 2025, 174 days after receiving the submission on April 11, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K251124 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2025
Decision Date October 02, 2025
Days to Decision 174 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200

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