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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 K112501
Device Name VENUS PEARL PLT REFILL A1
Applicant
Heraeus Kulzer, LLC
300 Heraeus Way
South Bend,  IN  46614
Applicant Contact CHERYL ZIMMERMAN
Correspondent
Heraeus Kulzer, LLC
300 Heraeus Way
South Bend,  IN  46614
Correspondent Contact CHERYL ZIMMERMAN
Regulation Number872.3690
Classification Product Code
EBF  
Date Received08/30/2011
Decision Date 12/14/2011
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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