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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 K052997
Device Name ZIMMER DENTAL ONE-PIECE IMPLANT
Applicant
ZIMMER DENTAL INC.
1900 ASTON AVE.
CARLSBAD,  CA  92008 -7308
Applicant Contact ERIN MCVEY
Correspondent
ZIMMER DENTAL INC.
1900 ASTON AVE.
CARLSBAD,  CA  92008 -7308
Correspondent Contact ERIN MCVEY
Regulation Number872.3640
Classification Product Code
DZE  
Date Received10/25/2005
Decision Date 01/23/2006
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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