FDA 510(k) Application Details - K042178

Device Classification Name	Bracket, Ceramic, Orthodontic   More FDA Info for this Device
510(K) Number	K042178
Device Name	Bracket, Ceramic, Orthodontic
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	872.5470   More FDA Info for this Regulation Number
Classification Product Code	NJM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/11/2004
Decision Date	08/30/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review