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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K043562
Device Name BC PLUS
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.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact CHAN YO WON
Regulation Number872.3200
Classification Product Code
KLE  
Date Received12/27/2004
Decision Date 01/03/2005
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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