FDA 510(k) Application Details - K000848

Device Classification Name	Handpiece, Air-Powered, Dental   More FDA Info for this Device
510(K) Number	K000848
Device Name	Handpiece, Air-Powered, Dental
Applicant	ORASYSTEMS 555 PASSAIC AVE. WEST CALDWELL, NJ 07006 US Other 510(k) Applications for this Company
Contact	BERNARD SESSMAN Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EFB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/15/2000
Decision Date	10/05/2000
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