GC OPB-100

Adhesive, Bracket And Tooth Conditioner, Resin

GC AMERICA, INC.

The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Opb-100.

Pre-market Notification Details

• Device ID: K080724
• 510k Number: K080724
• Device Name: GC OPB-100
• Classification: Adhesive, Bracket And Tooth Conditioner, Resin
• Applicant: GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803
• Contact: Mark Heiss
• Correspondent: Mark Heiss; GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803
• Product Code: DYH
• CFR Regulation Number: 872.3750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-03-14
• Decision Date: 2008-06-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D6584394661	K080724	000
10386040009836	K080724	000
10386040009829	K080724	000
14548161072632	K080724	000