FDA 510(k) Application Details - K242646

Device Classification Name	Controller, Foot, Handpiece And Cord   More FDA Info for this Device
510(K) Number	K242646
Device Name	Controller, Foot, Handpiece And Cord
Applicant	Guilin AestheDent Medical Instruments Co., Ltd 3rd Floor, Building 12th, Guilin Creative Industry Park No. 70, Qilidian Road, Qixing District Guilin 541004 CN Other 510(k) Applications for this Company
Contact	Chen Salon 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	09/03/2024
Decision Date	04/11/2025
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