GC Ortho Connect, GC Ortho Etching Gel— 510(k) K150128

Name: FDA 510(k) clearance K150128
Creator: U.S. Food and Drug Administration
Published: 2015-07-16

Substantially Equivalent

Gc Orthodontics America, Inc.

FDA 510(k) clearance K150128 for GC Ortho Connect, GC Ortho Etching Gel, Substantially Equivalent on 2015-07-16. Applicant: Gc Orthodontics America, Inc.. Device class: 2.

Clearance details

Applicant: Gc Orthodontics America, Inc.
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 2015-01-20
Decision date: 2015-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alsip, IL, US

Download summary PDF View on FDA.gov ↗

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