FDA 510(k) Application Details - K041141

Device Classification Name	Handpiece, Air-Powered, Dental   More FDA Info for this Device
510(K) Number	K041141
Device Name	Handpiece, Air-Powered, Dental
Applicant	DENTSPLY INTL. 221 WEST PHILADELPHIA STREET SUITE 60 YORK, PA 17404 US Other 510(k) Applications for this Company
Contact	P. JEFFERY LEHN 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	04/30/2004
Decision Date	06/16/2004
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