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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 K160398
Device Name MRI Compatibility for Existing Zimmer Dental Implant Systems
Applicant
Zimmer Dental, Inc.
1900 Aston Ave.
Carlsbad,  CA  92008
Applicant Contact Alex Eastes
Correspondent
Zimmer Dental, Inc.
1900 Aston Ave.
Carlsbad,  CA  92008
Correspondent Contact Christina Boydston
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received02/12/2016
Decision Date 05/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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