FDA 510(k) Application Details - K243911

Device Classification Name	Handpiece, Direct Drive, Ac-Powered   More FDA Info for this Device
510(K) Number	K243911
Device Name	Handpiece, Direct Drive, Ac-Powered
Applicant	Handpiece Headquarters 620 S. Placentia Avenue Placentia, CA 92870 US Other 510(k) Applications for this Company
Contact	Frederick Wang 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	12/19/2024
Decision Date	12/20/2024
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	Y
Expedited Review