FDA 510(k) Application Details - K100172

Device Classification Name	Varnish, Cavity   More FDA Info for this Device
510(K) Number	K100172
Device Name	Varnish, Cavity
Applicant	TOKUYAMA DENTAL CORPORATION 1425 K STREET, N.W. SUITE 1100 WASHINGTON, DC 20005 US Other 510(k) Applications for this Company
Contact	KEITH BARRITT 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	01/21/2010
Decision Date	10/21/2010
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