FDA 510(k) Application Details - K182145

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K182145
Device Name	Scaler, Ultrasonic
Applicant	Engineered Endodontics W134 N4965 Campbell Drive Menomonee Falls, WI 53051 US Other 510(k) Applications for this Company
Contact	Mark Fiorina Other 510(k) Applications for this Contact
Regulation Number	872.4850   More FDA Info for this Regulation Number
Classification Product Code	ELC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/08/2018
Decision Date	06/07/2019
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