EQUIA

Cement, Dental

GC AMERICA, INC.

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

Pre-market Notification Details

• Device ID: K091106
• 510k Number: K091106
• Device Name: EQUIA
• Classification: Cement, Dental
• 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: EMA
• CFR Regulation Number: 872.3275 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-04-16
• Decision Date: 2009-06-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00386040013874	K091106	000
00386040010552	K091106	000
00386040010545	K091106	000
00386040010538	K091106	000
00386040010521	K091106	000
00386040010514	K091106	000
00386040010507	K091106	000
00386040010491	K091106	000
00386040010484	K091106	000
00386040010477	K091106	000
00386040012624	K091106	000
00386040012617	K091106	000
00386040012600	K091106	000
00386040012594	K091106	000
00386040012648	K091106	000
00386040010569	K091106	000
00386040010576	K091106	000
00386040010583	K091106	000
10386040010849	K091106	000
00386040010835	K091106	000
00386040010828	K091106	000
00386040010811	K091106	000
00386040010804	K091106	000
00386040010798	K091106	000
00386040010781	K091106	000
00386040010774	K091106	000
00386040010767	K091106	000
00386040010637	K091106	000
00386040010620	K091106	000
00386040010613	K091106	000
00386040010606	K091106	000
00386040010590	K091106	000
00386040012631	K091106	000