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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 K122268
Device Name ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS
Applicant
DENTSPLY INTERNATIONAL
SUSQUEHANNA COMMERCE CTR. WEST
221 W. PHILADELPHIA ST., #60
YORK,  PA  17404
Applicant Contact HELEN LEWIS
Correspondent
DENTSPLY INTERNATIONAL
SUSQUEHANNA COMMERCE CTR. WEST
221 W. PHILADELPHIA ST., #60
YORK,  PA  17404
Correspondent Contact HELEN LEWIS
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/30/2012
Decision Date 12/11/2012
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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