FDA 510(k) Application Details - K232551

Device Classification Name	Handpiece, Direct Drive, Ac-Powered   More FDA Info for this Device
510(K) Number	K232551
Device Name	Handpiece, Direct Drive, Ac-Powered
Applicant	Forum Engineering Technologies (96) Ltd. 40 Hutsot Hayotser St Ashkelon 7878563 IL Other 510(k) Applications for this Company
Contact	Nissim Oz 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	08/23/2023
Decision Date	07/09/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review