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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 K102770
Device Name FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM 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 Number872.3660
Classification Product Code
ELW  
Date Received09/24/2010
Decision Date 12/21/2010
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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