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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K991450
Device Name ETCHING GEL
Applicant
Silicon-Und Composite Spezialitaten GmbH
Robert-Bosch-Strasse 5
Elmshorn,  DE D-25335
Applicant Contact JURGEN ENGELBRECHT
Correspondent
Silicon-Und Composite Spezialitaten GmbH
Robert-Bosch-Strasse 5
Elmshorn,  DE D-25335
Correspondent Contact JURGEN ENGELBRECHT
Regulation Number872.3690
Classification Product Code
EBF  
Date Received04/26/1999
Decision Date 07/09/1999
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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