FDA 510(k) Application Details - K984041

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K984041
Device Name	Material, Tooth Shade, Resin
Applicant	CAVEX HOLLAND B.V. 2003 RW HAARLEM PO BOX 852 HARMEN 19-21 NL Other 510(k) Applications for this Company
Contact	BERNARD VAN DUIJN 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	11/13/1998
Decision Date	12/04/1998
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