FDA 510(k) Application Details - K214078

Device Classification Name	More FDA Info for this Device
510(K) Number	K214078
Device Name	SilkÆn Toothwave
Applicant	Home Skinovations Ltd. Tabor Building, Shaar Yokneam Yoqneam Illit 2069200 IL Other 510(k) Applications for this Company
Contact	Amit Goren Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QMJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/27/2021
Decision Date	01/13/2023
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