510(k) K922627
- Device
- GORE-TEX REGENERATIVE MATERIAL
- Applicant
- W.L. GORE & ASSOCIATES,INC
- 510(k) number
- K922627
- Product code
- NPK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-06-10
- Date received
- 1992-06-03
- Regulation
- 872.3930
- Classification name
- Barrier, Synthetic, Intraoral
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY EDWARDS
- Address
- 1500 N. Fourth St. Flagstaff AZ US 86001 86001
FDA Registration Numbers#
- 3013820501
- 1018470
- 3027448274
- 9710629
- 2024024
- 1066741
- 3012101664
- 8044131
- 9681465
- 1650372
- 3002807310
- 3005115116
- 3006540014
- 8010177
- 3003300673
- 3017399129
- 3004431266
- 3014448321
- 2249852
- 2032542
- 1647149
- 9613348
- 3011276344
- 1221051
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NPK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221851 | Lumina-PTFE Titanium | Criteria Industria E Comercio DE Produtos Medicinais | 2023-12-08 |
| K222549 | OpenTex | Purgo Biologics, Inc. | 2023-05-11 |
| K211554 | InnoGenic Non-resorbable Membrane | Cowellmedi Co., Ltd. | 2023-02-24 |
| K210797 | Bio-MEM Ti Reinforced Membrane | B&Medi Co., Ltd. | 2022-08-18 |
| K201187 | Cytoplast Titanium-Reinforced PTFE Membranes | Osteogenics Biomedical, Inc. | 2021-01-23 |
| K171774 | RPM Reinforced PTFE Mesh | Osteogenics Biomedical, Inc. | 2017-10-19 |
| K160493 | Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm | Salvin Dental Specialties | 2016-09-08 |
| K151344 | Cytoflex Tefguard Ti-Enforced Membrane | Unicare Biomedical, Inc. | 2015-11-19 |
| K143327 | Neoss Ti Reinforced Membrane | Neoss, Ltd. | 2015-04-13 |
| K132325 | GUIDOR BIORESORBABLE MATRIX BARRIER | Sunstar Americas, Inc. | 2013-10-29 |
| K102184 | MEDPOR CONTAIN CAN IMPLANT | Porex Surgical, Inc. | 2011-01-07 |
| K101956 | STRAUMANN MEMBRAGEL | Straumann USA (On Behalf of Institut Straumann Ag) | 2010-12-16 |
| K091120 | MEDPOR CONTAIN IMPLANT | Porex Surgical, Inc. | 2010-03-19 |
| K082111 | STRAUMANN MEMBRAGEL | Institut Straumann AG | 2009-05-22 |
| K051267 | GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE | W. L. Gore & Associates, Inc. | 2005-06-15 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases