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
D0470015732	K001730	000
10386040009966	K001730	000
10386040009959	K001730	000
10386040009942	K001730	000
00386040009198	K001730	000
00386040009181	K001730	000