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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 (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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