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FDA 510(k) Application Details - K183121
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K183121
Device Name
Unit, Operative Dental
Applicant
AIOBIO Co., Ltd.
#306. Sunil Technopia 555, Dunchon-dacro, Jungwon-gu
Seongnam-si 13215 KR
Other 510(k) Applications for this Company
Contact
Jongcheol Yoon
Other 510(k) Applications for this Contact
Regulation Number
872.6640
More FDA Info for this Regulation Number
Classification Product Code
EIA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/09/2018
Decision Date
07/18/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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