FDA 510(k) Application Details - K110484

Device Classification Name	Crown And Bridge, Temporary, Resin   More FDA Info for this Device
510(K) Number	K110484
Device Name	Crown And Bridge, Temporary, Resin
Applicant	NOVOCOL, INC. 416 SOUTH TAYLOR AVE. LOUISVILLE, CO 80027 US Other 510(k) Applications for this Company
Contact	CORA BRACHO-TROCONIS Other 510(k) Applications for this Contact
Regulation Number	872.3770   More FDA Info for this Regulation Number
Classification Product Code	EBG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/18/2011
Decision Date	05/17/2011
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