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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 K120914
Models 66044871, 66044881, 66044882, 66045754, 66045755
Device Name FLEXITIME FAST & SCAN LIGHT FLOW
Original Applicant
HERAEUS KULZER, LLC
300 heraeus way
south bend,  IN  46614
Original Contact jamie mearna
Regulation Number872.3660
Classification Product Code
ELW  
Date Received03/27/2012
Decision Date 07/25/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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