FDA 510(k) Application Details - K970123

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K970123
Device Name	Scaler, Ultrasonic
Applicant	DENTSPLY INTL. 570 WEST COLLEGE AVE. YORK, PA 17405-0872 US Other 510(k) Applications for this Company
Contact	P. JEFFERY LEHN 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	01/14/1997
Decision Date	04/11/1997
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