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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 K022224
Device Name COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM
Applicant
Coltene AG
750 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact H.J. VOGELSTEIN
Correspondent
Coltene AG
750 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact H.J. VOGELSTEIN
Regulation Number872.3750
Classification Product Code
DYH  
Date Received07/10/2002
Decision Date 09/18/2002
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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