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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activator, Ultraviolet, For Polymerization
510(k) Number K173157
Device Name Dr's Light2
Applicant
Good Doctors Co., Ltd.
#208, B-Dong, 283 Bupyeong-Daero, Bupyeong-Gu
Incheon,  KR 21315
Applicant Contact Sungro Joo
Correspondent
LK Consulting Group USA, Inc.
690 Roosevelt
690 Roosevelt,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received09/29/2017
Decision Date 05/29/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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