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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 K091635
Device Name VENUS DIAMOND FLOW
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  
Subsequent Product Codes
EBC   LBH  
Date Received06/04/2009
Decision Date 09/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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