FDA 510(k) Application Details - K231391

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K231391
Device Name	Scaler, Ultrasonic
Applicant	Mectron S.p.A. Via Loreto 15/A Carasco 16042 IT Other 510(k) Applications for this Company
Contact	Edoardo Tronchet 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	05/12/2023
Decision Date	05/15/2023
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	Y
Expedited Review