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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name implant, endosseous, root-form
510(k) Number K121406
Device Name INCLUSIVE TAPERED IMPLANT SYSTEM
Original Applicant
PRISMATIK DENTALCRAFT, INC.
2212 dupont dr., st p
irvine,  CA  92612
Original Contact armin zehtabchi
Regulation Number872.3640
Classification Product Code
DZE  
Date Received05/10/2012
Decision Date 02/22/2013
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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