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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K981036
Device Name SMARTBOND
Applicant
Gac Intl., Inc.
185 Oval Dr.
Central Islip,  NY  11722
Applicant Contact MARK MANNI
Correspondent
Gac Intl., Inc.
185 Oval Dr.
Central Islip,  NY  11722
Correspondent Contact MARK MANNI
Regulation Number872.3750
Classification Product Code
DYH  
Date Received03/19/1998
Decision Date 04/05/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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