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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K080164
Device Name ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT
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 Number872.3630
Classification Product Code
NHA  
Date Received01/23/2008
Decision Date 09/25/2008
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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