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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 K193529
Device Name ATLANTIS Abutment for MIS Conical Connection Implants
Applicant
Dentsply Sirona
221 West Philadelphia Street, Suite 60W
York,  PA  17401
Applicant Contact Karl Nittinger
Correspondent
Dentsply Sirona
221 West Philadelphia Street, Suite 60W
York,  PA  17401
Correspondent Contact Karl Nittinger
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/20/2019
Decision Date 03/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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