G-Bond Universal— 510(k) K251124

Substantially Equivalent

GC America, Inc.

FDA 510(k) clearance K251124 for G-Bond Universal, Substantially Equivalent on 2025-10-02. Applicant: GC America, Inc.. Device class: 2.

Clearance details

Applicant: GC America, Inc.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2025-04-11
Decision date: 2025-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alsip, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.