FDA 510(k) Application Details - K120283

Device Classification Name	Cement, Dental   More FDA Info for this Device
510(K) Number	K120283
Device Name	Cement, Dental
Applicant	NOVOCOL, INC. 416 S Taylor Ave LOUISVILLE, CO 80027 US Other 510(k) Applications for this Company
Contact	CORA BRACHO-TROSONIS Other 510(k) Applications for this Contact
Regulation Number	872.3275   More FDA Info for this Regulation Number
Classification Product Code	EMA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/31/2012
Decision Date	07/31/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review