EXAFLEX IMPRESSION MATERIAL (MODIFICATION)

Material, Impression

GC AMERICA, INC.

The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Exaflex Impression Material (modification).

Pre-market Notification Details

• Device ID: K955932
• 510k Number: K955932
• Device Name: EXAFLEX IMPRESSION MATERIAL (MODIFICATION)
• Classification: Material, Impression
• Applicant: GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803
• Contact: Terry L Jortiz
• Correspondent: Terry L Jortiz; GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803
• Product Code: ELW
• CFR Regulation Number: 872.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-12-13
• Decision Date: 1996-03-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00386040013270	K955932	000
10386040001496	K955932	000
20386040006047	K955932	000
10386040001854	K955932	000
10386040004107	K955932	000
20386040005187	K955932	000
20386040005200	K955932	000
10386040005210	K955932	000
10386040005227	K955932	000
10386040005234	K955932	000
10386040005241	K955932	000
10386040005258	K955932	000
10386040005265	K955932	000
10386040005272	K955932	000
10386040005289	K955932	000
10386040005296	K955932	000
20386040005316	K955932	000
20386040000670	K955932	000
20386040000663	K955932	000
00386040013287	K955932	000
00386040013294	K955932	000
00386040013317	K955932	000
00386040013324	K955932	000
00386040013331	K955932	000
00386040013348	K955932	000
00386040013416	K955932	000
00386040013423	K955932	000
00386040013430	K955932	000
00386040013447	K955932	000
00386040013454	K955932	000
00386040013461	K955932	000
00386040013478	K955932	000
00386040013485	K955932	000
10386040012393	K955932	000
10386040000659	K955932	000
20386040005323	K955932	000
10386040005340	K955932	000
10386040005357	K955932	000
10386040005937	K955932	000
20386040005934	K955932	000
10386040005975	K955932	000
10386040005982	K955932	000
10386040006019	K955932	000
20386040006016	K955932	000
10386040006040	K955932	000
10386040006064	K955932	000
00386040006128	K955932	000
10386040006132	K955932	000
10386040006149	K955932	000
10386040006156	K955932	000
00386040006166	K955932	000
00386040006173	K955932	000
00386040006180	K955932	000
00386040006197	K955932	000
20386040005910	K955932	000
10386040005913	K955932	000
20386040005378	K955932	000
20386040005385	K955932	000
10386040005395	K955932	000
20386040005408	K955932	000
10386040005418	K955932	000
10386040005425	K955932	000
10386040005432	K955932	000
10386040005449	K955932	000
10386040005456	K955932	000
10386040005463	K955932	000
10386040005470	K955932	000
10386040005487	K955932	000
10386040005494	K955932	000
10386040005579	K955932	000
10386040005876	K955932	000
20386040005873	K955932	000
00386040006265	K955932	000