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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 K143528
Device Name Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System
Applicant
Zimmer Dental, Inc.
1900 Aston Ave.
Carlsbad,  CA  92008
Applicant Contact CHRISTINA BOYDSTON
Correspondent
Zimmer Dental, Inc.
1900 Aston Ave.
Carlsbad,  CA  92008
Correspondent Contact CHRISTINA BOYDSTON
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/12/2014
Decision Date 05/01/2015
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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