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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K122268
Device Name ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS
Original Applicant
DENTSPLY INTERNATIONAL
susquehanna commerce ctr. west
221 w. philadelphia st., #60
york,  PA  17404
Original Contact helen lewis
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/30/2012
Decision Date 12/11/2012
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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