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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light-Induced Fluorescence Caries Detector
510(k) Number K183471
Device Name IC-WHCD100 (Inspire)
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.
1150 Roosevelt Suite 200
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number872.1745
Classification Product Code
NBL  
Date Received12/14/2018
Decision Date 07/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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