GDLS-200

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 Gdls-200.

Pre-market Notification Details

• Device ID: K082434
• 510k Number: K082434
• Device Name: GDLS-200
• Classification: Material, Tooth Shade, 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: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-08-25
• Decision Date: 2008-11-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04548161291166	K082434	000
04548161291319	K082434	000
04548161291326	K082434	000
04548161291333	K082434	000
04548161291340	K082434	000
04548161291357	K082434	000
04548161291364	K082434	000
04548161291371	K082434	000
04548161291388	K082434	000
14548161293068	K082434	000
14548161293075	K082434	000
14548161293082	K082434	000
04548161291302	K082434	000
04548161291296	K082434	000
04548161291289	K082434	000
04548161291173	K082434	000
04548161291180	K082434	000
04548161291197	K082434	000
04548161291203	K082434	000
04548161291210	K082434	000
04548161291227	K082434	000
04548161291234	K082434	000
04548161291241	K082434	000
04548161291258	K082434	000
04548161291265	K082434	000
04548161291272	K082434	000
14548161293099	K082434	000
14548161293105	K082434	000
14548161293259	K082434	000
14548161293266	K082434	000
14548161293273	K082434	000
14548161293280	K082434	000
14548161293297	K082434	000
14548161293303	K082434	000
14548161293310	K082434	000
04548161293320	K082434	000
04548161293337	K082434	000
04548161293344	K082434	000
04548161322808	K082434	000
14548161293242	K082434	000
14548161293235	K082434	000
14548161293228	K082434	000
14548161293112	K082434	000
14548161293129	K082434	000
14548161293136	K082434	000
14548161293143	K082434	000
14548161293150	K082434	000
14548161293167	K082434	000
14548161293174	K082434	000
14548161293181	K082434	000
14548161293198	K082434	000
14548161293204	K082434	000
14548161293211	K082434	000
14548161322812	K082434	000