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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K183121
Device Name Qraypen
Applicant
AIOBIO Co., Ltd.
#306. Sunil Technopia 555, Dunchon-Dacro, Jungwon-Gu
Seongnam-Si,  KR 13215
Applicant Contact Jongcheol Yoon
Correspondent
Mdlab
Rm. 804, Botanic Park Tower Bldg., 161-17, Magokjungang-Ro,
Gangseo-Gu
Seoul,  KR 07788
Correspondent Contact Kyoungju Kim
Regulation Number872.6640
Classification Product Code
EIA  
Date Received11/09/2018
Decision Date 07/18/2019
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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