FDA 510(k) Application Details - K130862

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K130862
Device Name	Scaler, Ultrasonic
Applicant	DENTSPLY INTL., INC. 221 WEST PHILADELPHIA STREET SUITE 60 YORK, PA 17404 US Other 510(k) Applications for this Company
Contact	HELEN LEWIS 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	03/28/2013
Decision Date	07/23/2013
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