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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 K152845
Device Name Allied Biocompat Abutment for Nobel Replace Interface
Applicant
ALLIED DENTAL SOLUTIONS
1170 CENTRE DR #1
CITY OF INDUSTRY,  CA  91789
Applicant Contact Peter Zhou
Correspondent
BLACKWELL DEVICE CONSULTING
P.O. BOX 5845
STATESVILLE,  NC  28687 -5845
Correspondent Contact Angela Blackwell
Regulation Number872.3630
Classification Product Code
NHA  
Date Received09/29/2015
Decision Date 03/14/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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