Qraypen

Unit, Operative Dental

AIOBIO Co., Ltd.

The following data is part of a premarket notification filed by Aiobio Co., Ltd. with the FDA for Qraypen.

Pre-market Notification Details

Device IDK183121
510k NumberK183121
Device Name:Qraypen
ClassificationUnit, Operative Dental
Applicant AIOBIO Co., Ltd. #306. Sunil Technopia 555, Dunchon-dacro, Jungwon-gu Seongnam-si,  KR 13215
ContactJongcheol Yoon
CorrespondentKyoungju Kim
MDLab Room 804, Botanic Park Tower Bldg., 161-17, Magokjungang-ro, Gangseo-gu Seoul,  KR 07788
Product CodeEIA  
CFR Regulation Number872.6640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-09
Decision Date2019-07-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800043200038 K183121 000

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