FDA 510(k) Application Details - K011453

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K011453
Device Name	Material, Tooth Shade, Resin
Applicant	RITE-DENT MANUFACTURING CORP. 1056 EAST 33RD ST. HIALEAH, FL 33013-3526 US Other 510(k) Applications for this Company
Contact	CESAR E VELIZ 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	05/11/2001
Decision Date	07/23/2001
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