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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 K080265
Device Name DENFIL ETCHANT-37
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
UNDERWRITERS LABORATORIES, INC.
455 E. TRIMBLE ROAD
SAN JOSE,  CA  95131 -1230
Correspondent Contact MORTEN SIMON CHRISTENSEN
Regulation Number872.3690
Classification Product Code
EBF  
Date Received02/01/2008
Decision Date 02/06/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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