FDA 510(k) Application Details - K003482

Device Classification Name	Varnish, Cavity   More FDA Info for this Device
510(K) Number	K003482
Device Name	Varnish, Cavity
Applicant	ORTEK THERAPEUTICS, INC. 305 MADISON AVE. SUITE 2501 NEW YORK, NY 10165 US Other 510(k) Applications for this Company
Contact	JULES T MITCHEL Other 510(k) Applications for this Contact
Regulation Number	872.3260   More FDA Info for this Regulation Number
Classification Product Code	LBH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/09/2000
Decision Date	02/01/2001
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