FDA 510(k) Application Details - K981448

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K981448
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. ORANGE, CA 92667 US Other 510(k) Applications for this Company
Contact	WENDY A URTEL Other 510(k) Applications for this Contact
Regulation Number	872.3760   More FDA Info for this Regulation Number
Classification Product Code	EBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/1998
Decision Date	06/16/1998
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