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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 K072589
Device Name TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16
Applicant
ZIMMER DENTAL INC.
1900 ASTON AVE.
CARLSBAD,  CA  92008 -7308
Applicant Contact WILLIAM FISHER
Correspondent
ZIMMER DENTAL INC.
1900 ASTON AVE.
CARLSBAD,  CA  92008 -7308
Correspondent Contact WILLIAM FISHER
Regulation Number872.3640
Classification Product Code
DZE  
Date Received09/14/2007
Decision Date 10/04/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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