G-Fix

Material, Tooth Shade, Resin

GC America Inc.

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

Pre-market Notification Details

• Device ID: K151541
• 510k Number: K151541
• Device Name: G-Fix
• Classification: Material, Tooth Shade, Resin
• Applicant: GC America Inc. 3737 W. 127th Street Alsip, IL 60803
• Contact: Mark Heiss
• Correspondent: Mark Heiss; GC America Inc. 3737 W. 127th Street Alsip, IL 60803
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-06-08
• Decision Date: 2015-10-09
• Summary: summary