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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 K151039
Device Name ATLANTIS Abutment for NobelActive 3.0
Applicant
Dentsply International, Inc.
Susquehanna Commerce Ctr., 221
W. Philadelphia St., Suite 60
York,  PA  17401
Applicant Contact HELEN LEWIS
Correspondent
Dentsply International, Inc.
Susquehanna Commerce Ctr., 221
W. Philadelphia St., Suite 60
York,  PA  17401
Correspondent Contact HELEN LEWIS
Regulation Number872.3630
Classification Product Code
NHA  
Date Received04/20/2015
Decision Date 01/14/2016
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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