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 |
| 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 |
| K210797 | B&Medi Co., Ltd. | Bio-MEM Ti Reinforced Membrane | 08/18/2022 |
| K211554 | Cowellmedi Co., Ltd. | InnoGenic Non-resorbable Membrane | 02/24/2023 |
| 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 |
| K201187 | Osteogenics Biomedical, Inc. | Cytoplast Titanium-Reinforced PTFE Membranes | 01/23/2021 |
| 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 |
| K222549 | Purgo Biologics Inc. | OpenTex | 05/11/2023 |
| 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 |
| K151344 | Unicare Biomedical, Inc. | Cytoflex Tefguard Ti-Enforced Membrane | 11/19/2015 |
| K051267 | W.L. GORE & ASSOCIATES, INC. | GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE | 06/15/2005 |
| K960292 | W.L. GORE & ASSOCIATES,INC | GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS | 04/15/1996 |
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