FDA 510(k) Application Details - K122748

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K122748
Device Name	Scaler, Ultrasonic
Applicant	ENGLER ENGINEERING CORP. 1099 EAST 47TH ST. HIALEAH, FL 33013 US Other 510(k) Applications for this Company
Contact	JOEL KATZ 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	09/07/2012
Decision Date	06/11/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review