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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 K112160
Device Name TAPERED SCREW-VENT X IMPLANT
Applicant
ZIMMER DENTAL INC.
1900 ASTON AVE.
CARLSBAD,  CA  92008 -7308
Applicant Contact JEREMY MARKOVICH
Correspondent
ZIMMER DENTAL INC.
1900 ASTON AVE.
CARLSBAD,  CA  92008 -7308
Correspondent Contact JEREMY MARKOVICH
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/27/2011
Decision Date 12/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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