FDA 510(k) Application Details - K013869

Device Classification Name	Crown And Bridge, Temporary, Resin   More FDA Info for this Device
510(K) Number	K013869
Device Name	Crown And Bridge, Temporary, Resin
Applicant	IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. AMHERST, NY 14228 US Other 510(k) Applications for this Company
Contact	DONNA M HARTNETT 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	11/21/2001
Decision Date	08/28/2002
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