Barrier, Synthetic, Intraoral
Regulation 872.3930
0510(k)s in 12 months (31 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in NPK
| Company | 510(k)s | Recalls |
|---|---|---|
| W. L. Gore & Associates, Inc. | 5 | 0 |
| American Custom Medical, Inc. | 3 | 0 |
| Atrix Laboratories, Inc. | 2 | 0 |
| Imtec Corp. | 2 | 0 |
| Inion , Ltd. | 1 | 1 |
| Osteogenics Biomedical, Inc. | 2 | 0 |
| Porex Surgical, Inc. | 2 | 0 |
| B&Medi Co., Ltd. | 1 | 0 |
| Cowellmedi Co., Ltd. | 1 | 0 |
| Criteria Industria E Comercio DE Produtos Medicinais | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 8, 2023 | K221851 | Lumina-PTFE Titanium Criteria Industria E Comercio DE Produtos Medicinais, BR | NPK |
| May 11, 2023 | K222549 | OpenTex Purgo Biologics, Inc., KR | NPK |
| Feb 24, 2023 | K211554 | InnoGenic Non-resorbable Membrane Cowellmedi Co., Ltd., KR | NPK |
| Aug 18, 2022 | K210797 | Bio-MEM Ti Reinforced Membrane B&Medi Co., Ltd., KR | NPK |
| Jan 23, 2021 | K201187 | Cytoplast Titanium-Reinforced PTFE Membranes Osteogenics Biomedical, Inc. | NPK |
| Oct 19, 2017 | K171774 | RPM Reinforced PTFE Mesh Osteogenics Biomedical, Inc. | NPK |
| Sep 8, 2016 | K160493 | Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm Salvin Dental Specialties | NPK |
| Nov 19, 2015 | K151344 | Cytoflex Tefguard Ti-Enforced Membrane Unicare Biomedical, Inc. | NPK |
| Apr 13, 2015 | K143327 | Neoss Ti Reinforced Membrane Neoss, Ltd., GB | NPK |
| Oct 29, 2013 | K132325 | GUIDOR BIORESORBABLE MATRIX BARRIER Sunstar Americas, Inc. | NPK |
| Jan 7, 2011 | K102184 | MEDPOR CONTAIN CAN IMPLANT Porex Surgical, Inc. | NPK |
| Dec 16, 2010 | K101956 | STRAUMANN MEMBRAGEL Straumann USA (On Behalf of Institut Straumann Ag) | NPK |
| Mar 19, 2010 | K091120 | MEDPOR CONTAIN IMPLANT Porex Surgical, Inc. | NPK |
| May 22, 2009 | K082111 | STRAUMANN MEMBRAGEL Institut Straumann AG | NPK |
| Jun 15, 2005 | K051267 | GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE W. L. Gore & Associates, Inc. | NPK |
| Mar 31, 2004 | K033074 | INION GTR BIODEGRADABLE MEMBRANE SYSTEM Inion , Ltd., FI | NPK |
| Apr 9, 1999 | K990363 | BIOMESH BIODEGRADABLE GTR BARRIER Samyang Corp. | NPK |
| Sep 8, 1998 | K982865 | ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT Atrix Laboratories, Inc. | NPK |
| Mar 3, 1998 | K974752 | IMTEC/BIOBARRIER MEMBRANE Imtec Corp. | NPK |
| Aug 26, 1997 | K972240 | IMTEC BIOBARRIER MEMBRANE Imtec Corp. | NPK |
| Jun 11, 1997 | K960724 | BIO-GIDE RESORBABLE BILAYER MEMBRANE Geistlich-Pharma | NPK |
| Apr 30, 1997 | K965205 | TEFGEN - LS American Custom Medical, Inc. | NPK |
| Feb 10, 1997 | K964656 | TEFGEN GUIDED TISSUE MEMBRANE American Custom Medical, Inc. | NPK |
| May 20, 1996 | K955646 | VICRYL PERIDONTAL MESH ETHICON, Inc. | NPK |
| Apr 15, 1996 | K960292 | GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS W. L. Gore & Associates, Inc. | NPK |
| Mar 21, 1996 | K955838 | ATRISORB BIOABSORBABLE GUIDED TISSUE REGNERATION(GTR) Atrix Laboratories, Inc. | NPK |
| Aug 15, 1994 | K935137 | TEFGEN-FD American Custom Medical, Inc. | NPK |
| Jun 10, 1994 | K922627 | GORE-TEX REGENERATIVE MATERIAL W. L. Gore & Associates, Inc. | NPK |
| Nov 30, 1993 | K933541 | GORE-TEX PERIODONTAL MATERIAL - TITANIUM REINFORCED CONFIGURATIONS W. L. Gore & Associates, Inc. | NPK |
| May 13, 1993 | K912724 | GUIDOR(TM) Procordia Oratech AB, SE | NPK |
| May 19, 1986 | K854299 | GORE-TEX PERIODONTAL MATERIAL W. L. Gore & Associates, Inc. | NPK |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.