FDA 510(k) Application Details - K994012

Device Classification Name	Crown And Bridge, Temporary, Resin   More FDA Info for this Device
510(K) Number	K994012
Device Name	Crown And Bridge, Temporary, Resin
Applicant	DETAX GMBH & CO. KG 7707 E. 201 TERR BELTON, MO 64012 US Other 510(k) Applications for this Company
Contact	BARRY HALE Other 510(k) Applications for this Contact
Regulation Number	872.3770   More FDA Info for this Regulation Number
Classification Product Code	EBG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/26/1999
Decision Date	02/16/2000
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