FDA 510(k) Application Details - K003374

Device Classification Name	Crown And Bridge, Temporary, Resin   More FDA Info for this Device
510(K) Number	K003374
Device Name	Crown And Bridge, Temporary, Resin
Applicant	IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. AMHERST, NY 14228 US Other 510(k) Applications for this Company
Contact	ANDY GULATI 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	10/30/2000
Decision Date	12/04/2000
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