SMARTBOND

Adhesive, Bracket And Tooth Conditioner, Resin

GAC INTL., INC.

The following data is part of a premarket notification filed by Gac Intl., Inc. with the FDA for Smartbond.

Pre-market Notification Details

• Device ID: K981036
• 510k Number: K981036
• Device Name: SMARTBOND
• Classification: Adhesive, Bracket And Tooth Conditioner, Resin
• Applicant: GAC INTL., INC. 185 OVAL DR. Central Islip, NY 11722
• Contact: Mark Manni
• Correspondent: Mark Manni; GAC INTL., INC. 185 OVAL DR. Central Islip, NY 11722
• Product Code: DYH
• CFR Regulation Number: 872.3750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-03-19
• Decision Date: 1999-04-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07333117000025	K981036	000
07333117000018	K981036	000
07333117000063	K981036	000
07333117000056	K981036	000
07333117000049	K981036	000
07333117000032	K981036	000
10190886000595	K981036	000
10190886000588	K981036	000
10190886000571	K981036	000