FDA Product Code
FDA Product Code NPK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3930
510(k) Clearances — 31 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K221851 | Lumina-PTFE Titanium | Criteria Industria E Comercio DE Produtos Medicinais | 2023-12-08 | Traditional | PDF ↗ |
| K222549 | OpenTex | Purgo Biologics, Inc. | 2023-05-11 | Traditional | PDF ↗ |
| K211554 | InnoGenic Non-resorbable Membrane | Cowellmedi Co., Ltd. | 2023-02-24 | Traditional | PDF ↗ |
| K210797 | Bio-MEM Ti Reinforced Membrane | B&Medi Co., Ltd. | 2022-08-18 | Traditional | PDF ↗ |
| K201187 | Cytoplast Titanium-Reinforced PTFE Membranes | Osteogenics Biomedical, Inc. | 2021-01-23 | Traditional | PDF ↗ |
| K171774 | RPM Reinforced PTFE Mesh | Osteogenics Biomedical, Inc. | 2017-10-19 | Traditional | PDF ↗ |
| K160493 | Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm | Salvin Dental Specialties | 2016-09-08 | Traditional | PDF ↗ |
| K151344 | Cytoflex Tefguard Ti-Enforced Membrane | Unicare Biomedical, Inc. | 2015-11-19 | Traditional | PDF ↗ |
| K143327 | Neoss Ti Reinforced Membrane | Neoss, Ltd. | 2015-04-13 | Traditional | PDF ↗ |
| K132325 | GUIDOR BIORESORBABLE MATRIX BARRIER | Sunstar Americas, Inc. | 2013-10-29 | Abbreviated | PDF ↗ |
| K102184 | MEDPOR CONTAIN CAN IMPLANT | Porex Surgical, Inc. | 2011-01-07 | Traditional | PDF ↗ |
| K101956 | STRAUMANN MEMBRAGEL | Straumann USA (On Behalf of Institut Straumann Ag) | 2010-12-16 | Traditional | PDF ↗ |
| K091120 | MEDPOR CONTAIN IMPLANT | Porex Surgical, Inc. | 2010-03-19 | Traditional | PDF ↗ |
| K082111 | STRAUMANN MEMBRAGEL | Institut Straumann AG | 2009-05-22 | Traditional | PDF ↗ |
| K051267 | GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE | W. L. Gore & Associates, Inc. | 2005-06-15 | Traditional | PDF ↗ |
| K033074 | INION GTR BIODEGRADABLE MEMBRANE SYSTEM | Inion , Ltd. | 2004-03-31 | Traditional | PDF ↗ |
| K990363 | BIOMESH BIODEGRADABLE GTR BARRIER | Samyang Corp. | 1999-04-09 | Traditional | PDF ↗ |
| K982865 | ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT | Atrix Laboratories, Inc. | 1998-09-08 | Special | PDF ↗ |
| K974752 | IMTEC/BIOBARRIER MEMBRANE | Imtec Corp. | 1998-03-03 | Traditional | PDF ↗ |
| K972240 | IMTEC BIOBARRIER MEMBRANE | Imtec Corp. | 1997-08-26 | Traditional | PDF ↗ |
| K960724 | BIO-GIDE RESORBABLE BILAYER MEMBRANE | Geistlich-Pharma | 1997-06-11 | Traditional | PDF ↗ |
| K965205 | TEFGEN - LS | American Custom Medical, Inc. | 1997-04-30 | Traditional | PDF ↗ |
| K964656 | TEFGEN GUIDED TISSUE MEMBRANE | American Custom Medical, Inc. | 1997-02-10 | Traditional | PDF ↗ |
| K955646 | VICRYL PERIDONTAL MESH | ETHICON, Inc. | 1996-05-20 | Traditional | PDF ↗ |
| K960292 | GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS | W. L. Gore & Associates, Inc. | 1996-04-15 | Traditional | PDF ↗ |
| K955838 | ATRISORB BIOABSORBABLE GUIDED TISSUE REGNERATION(GTR) | Atrix Laboratories, Inc. | 1996-03-21 | Traditional | PDF ↗ |
| K935137 | TEFGEN-FD | American Custom Medical, Inc. | 1994-08-15 | Traditional | PDF ↗ |
| K922627 | GORE-TEX REGENERATIVE MATERIAL | W. L. Gore & Associates, Inc. | 1994-06-10 | Traditional | PDF ↗ |
| K933541 | GORE-TEX PERIODONTAL MATERIAL - TITANIUM REINFORCED CONFIGURATIONS | W. L. Gore & Associates, Inc. | 1993-11-30 | Traditional | PDF ↗ |
| K912724 | GUIDOR(TM) | Procordia Oratech AB | 1993-05-13 | Traditional | PDF ↗ |
| K854299 | GORE-TEX PERIODONTAL MATERIAL | W. L. Gore & Associates, Inc. | 1986-05-19 | Traditional | PDF ↗ |
Product code NPK · Class II · Dental. Data: openFDA.