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FDA 510(k) Application Details - K221741
Device Classification Name
Handpiece, Air-Powered, Dental
More FDA Info for this Device
510(K) Number
K221741
Device Name
Handpiece, Air-Powered, Dental
Applicant
Saeshin Precision Co., Ltd.
#52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun
Daegu 42921 KR
Other 510(k) Applications for this Company
Contact
Gung San Nam
Other 510(k) Applications for this Contact
Regulation Number
872.4200
More FDA Info for this Regulation Number
Classification Product Code
EFB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/15/2022
Decision Date
02/22/2023
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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