FDA 510(k) Application Details - K973539

Device Classification Name	Liner, Cavity, Calcium Hydroxide   More FDA Info for this Device
510(K) Number	K973539
Device Name	Liner, Cavity, Calcium Hydroxide
Applicant	ROEKO USA, INC. 100 MAIN STREET,STE. 120 CONCORD, MA 01742 US Other 510(k) Applications for this Company
Contact	JAMES DELANEY Other 510(k) Applications for this Contact
Regulation Number	872.3250   More FDA Info for this Regulation Number
Classification Product Code	EJK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/18/1997
Decision Date	10/30/1997
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