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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 K122424
Device Name ISUS IMPLANT SUPRASTRUCTURES
Original Applicant
DENTSPLY INTERNATIONAL, INC.
susquehanna commerce ctr., 221
w. philadelphia st.
york,  PA  17404
Original Contact helen lewis
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/09/2012
Decision Date 07/05/2013
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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