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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 K113574
Device Name FLEXITIME MONOPHASE PRO SCAN
Applicant
Heraeus Kulzer, LLC
300 Heraeus Way
South Bend,  IN  46614
Applicant Contact CHRIS HOLDEN
Correspondent
Heraeus Kulzer, LLC
300 Heraeus Way
South Bend,  IN  46614
Correspondent Contact CHRIS HOLDEN
Regulation Number872.3660
Classification Product Code
ELW  
Date Received12/02/2011
Decision Date 07/13/2012
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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