FDA 510(k) Application Details - K223340

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K223340
Device Name	Scaler, Ultrasonic
Applicant	Essential Dental Systems Inc. 89 Leuning Street South Hackensack, NJ 07606 US Other 510(k) Applications for this Company
Contact	Jason Guzman 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	11/01/2022
Decision Date	12/11/2023
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