FDA 510(k) Application Details - K062518

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K062518
Device Name	Material, Tooth Shade, Resin
Applicant	PARKELL, INC. 300 EXECUTIVE DR. EDGEWOOD, NY 11717 US Other 510(k) Applications for this Company
Contact	NELSON J GENDUSA Other 510(k) Applications for this Contact
Regulation Number	872.3690   More FDA Info for this Regulation Number
Classification Product Code	EBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/2006
Decision Date	12/04/2006
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