FDA 510(k) Application Details - K051910

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K051910
Device Name	Scaler, Ultrasonic
Applicant	D.B.I. AMERICA CORP. 2909 BUSCH LAKE BLVD. TAMPA, FL 33614 US Other 510(k) Applications for this Company
Contact	UBIRACI R FERNANDES 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	07/14/2005
Decision Date	09/02/2005
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