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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name crown and bridge, temporary, resin
510(k) Number K122039
Device Name KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B
Original Applicant
KETTENBACH GMBH & CO KG
im heerfeld 7
eschenburg,  GM 35713
Original Contact juergen berger
Regulation Number872.3770
Classification Product Code
EBG  
Date Received07/11/2012
Decision Date 12/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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