FDA 510(k) Application Details - K231864

Device Classification Name	Controller, Foot, Handpiece And Cord   More FDA Info for this Device
510(K) Number	K231864
Device Name	Controller, Foot, Handpiece And Cord
Applicant	Codent Technical Industry Co., Ltd. 2F., No.100, Luke 5th Rd., Luzhu Dist. Kaohsiung City 821 TW Other 510(k) Applications for this Company
Contact	Jyun-Ming Shuo Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EBW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/26/2023
Decision Date	03/11/2024
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