FDA 510(k) Application Details - K023819

Device Classification Name	Gutta-Percha   More FDA Info for this Device
510(K) Number	K023819
Device Name	Gutta-Percha
Applicant	PENTRON CLINICAL TECHNOLOGIES 53 NORTH PLAINS INDUSTRIAL RD. WALLINGFORD, CT 06492-0724 US Other 510(k) Applications for this Company
Contact	ANNMARIE TENERO Other 510(k) Applications for this Contact
Regulation Number	872.3850   More FDA Info for this Regulation Number
Classification Product Code	EKM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2002
Decision Date	03/26/2003
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