G-BOND

Agent, Tooth Bonding, Resin

GC AMERICA INC.

The following data is part of a premarket notification filed by Gc America Inc. with the FDA for G-bond.

Pre-market Notification Details

• Device ID: K041471
• 510k Number: K041471
• Device Name: G-BOND
• Classification: Agent, Tooth Bonding, Resin
• Applicant: GC AMERICA INC. 3737 WEST 127TH STREET Alsip, IL 60803
• Contact: Terry L Joritz
• Correspondent: Terry L Joritz; GC AMERICA INC. 3737 WEST 127TH STREET Alsip, IL 60803
• Product Code: KLE
• CFR Regulation Number: 872.3200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-06-02
• Decision Date: 2004-06-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
14548161074728	K041471	000
04548161075667	K041471	000
D0470023021	K041471	000
D0470022771	K041471	000