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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K953476
Device Name MULTI-PRIME AKA/MONO-PRIME
Applicant
Silicon-Und Composite Spezialitaten GmbH
Offenauer Weg 19
Bokholt-Hanredder,  DE D-25335
Applicant Contact JURGEN ENGLEBRECHT
Correspondent
Silicon-Und Composite Spezialitaten GmbH
Offenauer Weg 19
Bokholt-Hanredder,  DE D-25335
Correspondent Contact JURGEN ENGLEBRECHT
Regulation Number872.3200
Classification Product Code
KLE  
Date Received07/24/1995
Decision Date 09/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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