FDA 510(k) Applications for Medical Device Product Code "EKM"
(Gutta-Percha)

FDA 510(k) Number Applicant Device Name Decision Date
K971641 DR. HOWARD MARTIN, P.A. ANTIBACTERIAL GUTTA PERCHA 07/21/1997
K051573 DR. HOWARD MARTIN, P.A. TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) 06/26/2006
K070246 ENDO TWINN B.V. DOWN PAK 02/16/2007
K042870 ENDO TWINN B.V. ENDO TWINN 01/11/2005
K073369 HU-FRIEDY MFG. CO., INC EI DOWNPAK BARRIER SLEEVES 02/27/2008
K023819 PENTRON CLINICAL TECHNOLOGIES FIBERFILL SGP 03/26/2003
K970134 TULSA DENTAL PRODUCTS, LTD. THERMAPREP PLUS OVEN 03/21/1997


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact