FDA 510(k) Application Details - K081550

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K081550
Device Name	Scaler, Ultrasonic
Applicant	BONART CO. LTD. 398 S. LEMON CREEK DR. STE. L WALNUT, CA 91789 US Other 510(k) Applications for this Company
Contact	ERIC L ONG 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	06/03/2008
Decision Date	08/28/2008
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