FDA 510(k) Application Details - K110178

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K110178
Device Name	Material, Tooth Shade, Resin
Applicant	TOKUYAMA DENTAL CORPORATION 1425 K STREET, N.W. SUITE 1100 WASHINGTON, DC 20005 US Other 510(k) Applications for this Company
Contact	KEITH A BARRITT Other 510(k) Applications for this Contact
Regulation Number	872.3690   More FDA Info for this Regulation Number
Classification Product Code	EBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/21/2011
Decision Date	04/05/2011
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