FDA 510(k) Application Details - K060171

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K060171
Device Name	Scaler, Ultrasonic
Applicant	DMETEC CO., LTD. 55 NORTHERN BLVD., SUITE 200 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	CAROLANN KOTULA 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	01/23/2006
Decision Date	03/29/2006
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