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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K992001
Device Name TRAY-LINK
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 Number872.3660
Classification Product Code
ELW  
Date Received06/15/1999
Decision Date 11/02/1999
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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