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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K060637
Device Name DENFIL FLOW
Applicant
Vericom Co., Ltd.
#606,5th Dongyoung Venturestel
199-32, Anyang 7-Dong,Manan-Gu
Anyang-Si, Gyeonggi-Do,  KR 430-817
Applicant Contact MYUNG-HWAN OH
Correspondent
Bsi Healthcare
Kitemark Ct., Davy Ave.
Knowlhill
Milton Keynes,  GB MK5 8PP
Correspondent Contact JOHN HOWLETT
Regulation Number872.3690
Classification Product Code
EBF  
Date Received03/10/2006
Decision Date 03/16/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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