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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 Rd.
San Jose,  CA  95131
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
Predetermined Change
Control Plan Authorized		 No
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