GRADIA DIRECT

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 Gradia Direct.

Pre-market Notification Details

• Device ID: K023814
• 510k Number: K023814
• Device Name: GRADIA DIRECT
• Classification: Material, Tooth Shade, Resin
• 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: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-11-15
• Decision Date: 2003-01-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04548161073496	K023814	000
04548161073663	K023814	000
04548161073670	K023814	000
04548161073687	K023814	000
04548161073694	K023814	000
14548161073707	K023814	000
14548161073714	K023814	000
14548161073721	K023814	000
14548161073738	K023814	000
14548161073745	K023814	000
14548161073752	K023814	000
14548161073783	K023814	000
04548161073793	K023814	000
04548161073656	K023814	000
04548161073649	K023814	000
04548161073502	K023814	000
04548161073519	K023814	000
04548161073526	K023814	000
04548161073533	K023814	000
04548161073540	K023814	000
04548161073571	K023814	000
04548161073588	K023814	000
04548161073595	K023814	000
04548161073601	K023814	000
04548161073618	K023814	000
04548161073625	K023814	000
04548161073632	K023814	000
04548161073809	K023814	000
04548161073816	K023814	000
14548161074162	K023814	000
14548161074179	K023814	000
14548161074186	K023814	000
14548161074193	K023814	000
14548161074209	K023814	000
14548161074216	K023814	000
14548161074223	K023814	000
14548161074230	K023814	000
14548161074247	K023814	000
04548161075292	K023814	000
04548161075308	K023814	000
14548161075312	K023814	000
14548161074155	K023814	000
14548161074148	K023814	000
04548161073823	K023814	000
04548161073847	K023814	000
14548161073851	K023814	000
14548161073868	K023814	000
14548161073875	K023814	000
14548161073882	K023814	000
14548161073905	K023814	000
04548161074097	K023814	000
04548161074103	K023814	000
14548161074117	K023814	000
14548161074124	K023814	000
14548161074131	K023814	000
14548161075329	K023814	000