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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 K121709
Device Name ZFX DENTAL CAD SYSTEM
Original Applicant
ZIMMER DENTAL INC.
1900 aston ave.
carlsbad,  CA  92008 7308
Original Contact cecilia silva
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
NOF  
Date Received06/11/2012
Decision Date 10/19/2012
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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