FDA 510(k) Application Details - K981383

Device Classification Name	Agent, Tooth Bonding, Resin   More FDA Info for this Device
510(K) Number	K981383
Device Name	Agent, Tooth Bonding, Resin
Applicant	SOUTHERN DENTAL INDUSTRIES, INC. 246 FIRST ST., SUITE 204 SAN FRANCISCO, CA 94105 US Other 510(k) Applications for this Company
Contact	SAMANTHA J CHEETHAM Other 510(k) Applications for this Contact
Regulation Number	872.3200   More FDA Info for this Regulation Number
Classification Product Code	KLE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/16/1998
Decision Date	06/16/1998
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