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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 K131644
Device Name ANKYLOS SYNCONE ABUTMENT 5(DEGREE)
Applicant
DENTSPLY INTERNATIONAL, INC.
221 WEST PHILADELPHIA ST.
SUITE 60
YORK,  PA  17404
Applicant Contact HELEN LEWIS
Correspondent
DENTSPLY INTERNATIONAL, INC.
221 WEST PHILADELPHIA ST.
SUITE 60
YORK,  PA  17404
Correspondent Contact HELEN LEWIS
Regulation Number872.3630
Classification Product Code
NHA  
Date Received06/05/2013
Decision Date 01/22/2014
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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