FDA 510(k) Application Details - K983477

Device Classification Name	Liner, Cavity, Calcium Hydroxide   More FDA Info for this Device
510(K) Number	K983477
Device Name	Liner, Cavity, Calcium Hydroxide
Applicant	PHOENIX DENTAL, INC. 3452 WEST THOMPSON RD. FENTON, MI 48430 US Other 510(k) Applications for this Company
Contact	ROBERT A CHERBA 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	10/02/1998
Decision Date	12/22/1998
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