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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 K143505
Device Name Zimmer Patient-Specific Abutment, Internal Hex, Titanium
Zimmer Dental, Inc.
1900 Aston Ave.
Carldsbad,  CA  92008
Applicant Contact Christina Boydston
Zimmer Dental, Inc.
1900 Aston Ave.
Carldsbad,  CA  92008
Correspondent Contact Christina Boydston
Regulation Number872.3630
Classification Product Code
Date Received12/10/2014
Decision Date 06/25/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No