FDA 510(k) Application Details - K212043

Device Classification Name	Handpiece, Direct Drive, Ac-Powered   More FDA Info for this Device
510(K) Number	K212043
Device Name	Handpiece, Direct Drive, Ac-Powered
Applicant	Saeshin Precision Co., Ltd. # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun Daegu 711-814 KR Other 510(k) Applications for this Company
Contact	Nam-Gung San Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/30/2021
Decision Date	06/24/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review