FDA 510(k) Application Details - K233922

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K233922
Device Name	Scaler, Ultrasonic
Applicant	SATELEC-ACTEON GROUP 17 Avenue Gustave Eiffel ZI du Phare Merignac 33708 FR Other 510(k) Applications for this Company
Contact	Philippe Girard 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	12/13/2023
Decision Date	03/11/2024
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