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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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