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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
Predetermined Change
Control Plan Authorized		 No
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