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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 K113753
Device Name ZIMMER DENTAL TAPERED SCREW-VENT X
Original Applicant
ZIMMER DENTAL INC.
1900 aston ave.
carlsbad,  CA  92008 -7308
Original Contact melissa burbage
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/21/2011
Decision Date 08/30/2012
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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