GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS
FDA 510(k) clearance K960292 · decided 1996-04-15
Clearance details
- K-number
- K960292
- Device name
- GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS
- Applicant
- W. L. Gore & Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-01-22
- Decision date
- 1996-04-15
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- NPK
- Device class
- 2
- Regulation number
- 872.3930
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Flagstaff, AZ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch W. L. Gore & Associates
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Lumina-PTFE Titanium (K221851) | Criteria Industria E Comercio DE Produtos Medicinais | 2023-12-08 |
| OpenTex (K222549) | Purgo Biologics, Inc. | 2023-05-11 |
| InnoGenic Non-resorbable Membrane (K211554) | Cowellmedi Co., Ltd. | 2023-02-24 |
| Bio-MEM Ti Reinforced Membrane (K210797) | B&Medi Co., Ltd. | 2022-08-18 |
| Cytoplast Titanium-Reinforced PTFE Membranes (K201187) | Osteogenics Biomedical, Inc. | 2021-01-23 |
| RPM Reinforced PTFE Mesh (K171774) | Osteogenics Biomedical, Inc. | 2017-10-19 |
| Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm (K160493) | Salvin Dental Specialties | 2016-09-08 |
| Cytoflex Tefguard Ti-Enforced Membrane (K151344) | Unicare Biomedical, Inc. | 2015-11-19 |
| Neoss Ti Reinforced Membrane (K143327) | Neoss, Ltd. | 2015-04-13 |
| GUIDOR BIORESORBABLE MATRIX BARRIER (K132325) | Sunstar Americas, Inc. | 2013-10-29 |
| MEDPOR CONTAIN CAN IMPLANT (K102184) | Porex Surgical, Inc. | 2011-01-07 |
| STRAUMANN MEMBRAGEL (K101956) | Straumann USA (On Behalf of Institut Straumann Ag) | 2010-12-16 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GORE® VIABAHN® FORTEGRA Venous Stent (P250017) | W. L. Gore & Associates, Inc. | 2025-12-19 |
| GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder (P050006/S116) | W. L. Gore & Associates, Inc. | 2025-12-19 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S048) | W. L. Gore & Associates, Inc. | 2025-11-24 |
| GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (P040027/S099) | W. L. Gore & Associates, Inc. | 2025-10-27 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S110) | W. L. Gore & Associates, Inc. | 2025-10-17 |
| GORE® VIABAHN® Endoprosthesis; GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S171) | W. L. Gore & Associates, Inc. | 2025-10-17 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S024) | W. L. Gore & Associates, Inc. | 2025-10-17 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S049) | W. L. Gore & Associates, Inc. | 2025-10-17 |