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 |