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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 K163398
Device Name ATLANTIS suprastructures
Applicant
Dentsply Sirona
221 W. Philadelphia St., Suite 60
York,  PA  17404
Applicant Contact Karl Nittinger
Correspondent
Dentsply Sirona
221 W. Philadelphia St., Suite 60
York,  PA  17404
Correspondent Contact Karl Nittinger
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/05/2016
Decision Date 08/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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