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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 K221275
Device Name Qraycam PRO
Applicant
AIOBIO Co., Ltd.
#306 Sunil Technopia, 555 Dunchon-Daero
Jungwon-Gu
Seongnam-Si,  KR 13215
Applicant Contact HongCheol Yoon
Correspondent
KMC, Inc.
Rm. # 1709, 123, Digital-Ro 26-Gil, Guro-Gu
Seoul,  KR 08390
Correspondent Contact JeongKeun Kim
Regulation Number872.1745
Classification Product Code
NBL  
Date Received05/02/2022
Decision Date 09/04/2024
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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