FDA 510(k) Application Details - DEN190039

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN190039
Device Name	ToothWaveÖ
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	08/22/2019
Decision Date	09/17/2020
Decision	DENG -
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review