FDA 510(k) Application Details - K093059

Device Classification Name	Sealant, Pit And Fissure, And Conditioner   More FDA Info for this Device
510(K) Number	K093059
Device Name	Sealant, Pit And Fissure, And Conditioner
Applicant	CLASSONE ORTHODONTICS, INC. 5064 50TH ST. LUBBOCK, TX 79414 US Other 510(k) Applications for this Company
Contact	JUDY RIBORDY Other 510(k) Applications for this Contact
Regulation Number	872.3765   More FDA Info for this Regulation Number
Classification Product Code	EBC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2009
Decision Date	02/04/2010
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