GC FUJICEM

Cement, Dental

GC AMERICA, INC.

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

Pre-market Notification Details

• Device ID: K001730
• 510k Number: K001730
• Device Name: GC FUJICEM
• Classification: Cement, Dental
• 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: EMA
• CFR Regulation Number: 872.3275 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-06-07
• Decision Date: 2000-07-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D0470046471	K001730	000
D6584410011	K001730	000
D6584410021	K001730	000
00386040009181	K001730	000
00386040009198	K001730	000
10386040009942	K001730	000
10386040009959	K001730	000
10386040009966	K001730	000
D0470015732	K001730	000
D6584410001	K001730	000