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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 K141970
Device Name DIGITEK TITANIUM ABUTMENT
Applicant
DIGITEK DENTAL SOLUTIONS LIMITED
93 KINGLAM ST, CHEUNG SHA WAN
UNITS B-C FLAT D, 6/F
KOWLOON, HONG KONG,  CN 999077
Applicant Contact ALWIN NGAI
Correspondent
DIGITEK DENTAL SOLUTIONS LIMITED
93 KINGLAM ST, CHEUNG SHA WAN
UNITS B-C FLAT D, 6/F
KOWLOON, HONG KONG,  CN 999077
Correspondent Contact ALWIN NGAI
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/21/2014
Decision Date 07/31/2015
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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