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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 K031420
Device Name S & C -BRACKET ADHESIVES
Applicant
S & C Polymer GmbH
Robert-Bosch-Strasse 5
Elmshorn,  DE D-25335
Applicant Contact CHRISTIAN BOETTTCHER
Correspondent
S & C Polymer GmbH
Robert-Bosch-Strasse 5
Elmshorn,  DE D-25335
Correspondent Contact CHRISTIAN BOETTTCHER
Regulation Number872.3750
Classification Product Code
DYH  
Date Received05/05/2003
Decision Date 08/20/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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