FDA 510(k) Application Details - K112517

Device Classification Name	Sealant, Pit And Fissure, And Conditioner   More FDA Info for this Device
510(K) Number	K112517
Device Name	Sealant, Pit And Fissure, And Conditioner
Applicant	ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH SOUTH JORDAN, UT 84095 US Other 510(k) Applications for this Company
Contact	DIANE ROGERS 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	08/31/2011
Decision Date	09/23/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review