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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
Device Name FLEXITIME FAST & SCAN LIGHT FLOW
Applicant
HERAEUS KULZER, LLC
300 heraeus way
south bend,  IN  46614
Applicant Contact jamie mearna
Correspondent
HERAEUS KULZER, LLC
300 heraeus way
south bend,  IN  46614
Correspodent Contact jamie mearna
Regulation Number872.3660
Classification Product Code
ELW  
Date Received03/27/2012
Decision Date 07/25/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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