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
D6584520001	K091106	000
D6584530000	K091106	000
D6584530010	K091106	000
D6584530020	K091106	000
D6584530030	K091106	000
D6584530040	K091106	000
D6584530050	K091106	000
D6584530060	K091106	000
D6584530070	K091106	000
D6584530080	K091106	000
D6584530090	K091106	000
D6584530100	K091106	000
D6584530110	K091106	000
D6584530120	K091106	000
D6584530130	K091106	000
D6584530140	K091106	000
D6584520171	K091106	000
D6584520161	K091106	000
D6584520011	K091106	000
D6584520021	K091106	000
D6584520031	K091106	000
D6584520041	K091106	000
D6584520051	K091106	000
D6584520061	K091106	000
D6584520071	K091106	000
D6584520081	K091106	000
D6584520091	K091106	000
D6584520101	K091106	000
D6584520111	K091106	000
D6584520121	K091106	000
D6584520131	K091106	000
D6584520141	K091106	000
D6584520151	K091106	000
D6584530150	K091106	000
D6584530160	K091106	000
D6584530170	K091106	000
00386040010583	K091106	000
00386040010590	K091106	000
00386040010606	K091106	000
00386040010613	K091106	000
00386040010620	K091106	000
00386040010637	K091106	000
00386040010767	K091106	000
00386040010774	K091106	000
00386040010781	K091106	000
00386040010798	K091106	000
00386040010804	K091106	000
00386040010811	K091106	000
00386040010828	K091106	000
00386040010835	K091106	000
10386040010849	K091106	000
00386040010576	K091106	000
00386040010569	K091106	000
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00386040012648	K091106	000
00386040012594	K091106	000
00386040012600	K091106	000
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00386040012624	K091106	000
00386040010477	K091106	000
00386040010484	K091106	000
00386040010491	K091106	000
00386040010507	K091106	000
00386040010514	K091106	000
00386040010521	K091106	000
00386040010538	K091106	000
00386040010545	K091106	000
00386040010552	K091106	000
00386040013874	K091106	000