FDA 510(k) Applications for Medical Device Product Code "NPK"
(Barrier, Synthetic, Intraoral)

FDA 510(k) Number Applicant Device Name Decision Date
K965205 AMERICAN CUSTOM MEDICAL, INC. TEFGEN - LS 04/30/1997
K964656 AMERICAN CUSTOM MEDICAL, INC. TEFGEN GUIDED TISSUE MEMBRANE 02/10/1997
K935137 AMERICAN CUSTOM MEDICAL, INC. TEFGEN-FD 08/15/1994
K982865 ATRIX LABORATORIES, INC. ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT 09/08/1998
K955838 ATRIX LABORATORIES, INC. ATRISORB BIOABSORBABLE GUIDED TISSUE REGNERATION(GTR) 03/21/1996
K955646 ETHICON, INC. VICRYL PERIDONTAL MESH 05/20/1996
K960724 GEISTLICH-PHARMA BIO-GIDE RESORBABLE BILAYER MEMBRANE 06/11/1997
K972240 IMTEC CORP. IMTEC BIOBARRIER MEMBRANE 08/26/1997
K974752 IMTEC CORP. IMTEC/BIOBARRIER MEMBRANE 03/03/1998
K033074 INION LTD. INION GTR BIODEGRADABLE MEMBRANE SYSTEM 03/31/2004
K082111 INSTITUT STRAUMANN AG STRAUMANN MEMBRAGEL 05/22/2009
K143327 Neoss Ltd Neoss Ti Reinforced Membrane 04/13/2015
K171774 Osteogenics Biomedical, Inc. RPM Reinforced PTFE Mesh 10/19/2017
K102184 POREX SURGICAL, INC. MEDPOR CONTAIN CAN IMPLANT 01/07/2011
K091120 POREX SURGICAL, INC. MEDPOR CONTAIN IMPLANT 03/19/2010
K912724 PROCORDIA ORATECH AB GUIDOR(TM) 05/13/1993
K160493 Salvin Dental Specialties Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm 09/08/2016
K990363 SAMYANG CORP. BIOMESH BIODEGRADABLE GTR BARRIER 04/09/1999
K101956 STRAUMANN USA (ON BEHALF OF INSTITUT STRAUMANN AG) STRAUMANN MEMBRAGEL 12/16/2010
K132325 SUNSTAR AMERICAS, INC. GUIDOR BIORESORBABLE MATRIX BARRIER 10/29/2013
K051267 W.L. GORE & ASSOCIATES, INC. GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE 06/15/2005
K854299 W.L. GORE & ASSOCIATES,INC GORE-TEX PERIODONTAL MATERIAL 05/19/1986
K933541 W.L. GORE & ASSOCIATES,INC GORE-TEX PERIODONTAL MATERIAL - TITANIUM REINFORCED CONFIGURATIONS 11/30/1993
K922627 W.L. GORE & ASSOCIATES,INC GORE-TEX REGENERATIVE MATERIAL 06/10/1994
K960292 W.L. GORE & ASSOCIATES,INC GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS 04/15/1996


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