GC RELINE

Resin, Denture, Relining, Repairing, Rebasing

GC AMERICA, INC.

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

Pre-market Notification Details

• Device ID: K982695
• 510k Number: K982695
• Device Name: GC RELINE
• Classification: Resin, Denture, Relining, Repairing, Rebasing
• Applicant: GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803
• Contact: Terry L Joritz
• Correspondent: Terry L Joritz; GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803
• Product Code: EBI
• CFR Regulation Number: 872.3760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-08-03
• Decision Date: 1998-10-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10386040007078	K982695	000
10386040003766	K982695	000
10386040000871	K982695	000