LINKMAX

Cement, Dental

GC AMERICA, INC.

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

Pre-market Notification Details

• Device ID: K001823
• 510k Number: K001823
• Device Name: LINKMAX
• 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: 2000-06-16
• Decision Date: 2000-08-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04548161297304	K001823	000
14548161282611	K001823	000