Not currently registered with FDA under this name
W. L. Gore & Associates, Inc.
Flagstaff, AZ, United States. Named as applicant on 11 dental 510(k) clearances between 1986 and 2005. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 111986–2005
- Markets registered in
- 15956 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 15 markets
Where regulators' registries name W. L. Gore & Associates, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | W. L. Gore & Associates, Inc. | 11 clearances | 1986–2005 | Below |
| European Union | EUDAMED | Manufacturer | W. L. Gore & Associates, Inc. | 315 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | W.L. GORE & ASSOCIATES, INC.W.L GORE & ASSOCIATES INC · W. L. GORE & ASSOCIATES · +2 | 258 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | W.L. GORE & ASSOCIATES, INC. | 97 | 1999–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | W.L. Gore & Associates Inc.W. L. Gore & Associates, Inc. | 56 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | W.L. GORE & ASSOCIATES INC.W.L. GORE & ASSOCIATES, INC. · W.L. Gore & Associates, Inc. | 41 | 1979–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | WL Gore & Associates Inc | 39 | 2003–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | W.L. GORE & ASSOCIATES INCW.L. GORE & ASSOCIATES, INC. · W. L. GORE & ASSOCIATES, INC. · +1 | 28 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | W.L Gore & Associates IncW.L.Gore & Associates, Inc. · W.L Gore & Associates, Inc. · +2 | 25 | 1998–2019 | Pure Global AI |
| China | NMPA | Registration holder | 戈尔及同仁有限公司W.L. Gore & Associates, Inc.戈尔及同仁有限公司W.L. GORE & ASSOCIATES, INC. · 戈尔及同仁有限公司 W.L. GORE & ASSOCIATES, INC. · +2 | 24 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | W.L. Gore & Associates, Inc. | 23 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | W.L. GORE & ASSOCIATES, INC.W.L. GORE & ASSOCIATES, INC · W. L. GORE & ASSOCIATES, INC · +1 | 21 | 2008–2026 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | W.L. Gore & Associates, Inc.W. L. Gore & Associates, Inc. · W.L. Gore & Associates, Inc · +2 | 15 | 2015–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | W.L.Gore & Associates Inc.W.L.Gore & Associates Inc | 13 | — | Pure Global AI |
| Mexico | COFEPRIS | Registration holder | W.L. GORE & ASSOCIATES, INC. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names W. L. Gore & Associates, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 15 Jun 2005 | K051267 | GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE | NPK Intraoral Synthetic Barrier |
| 19 Dec 2001 | K013346 | GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE | LYC Synthetic Bone Grafting Material |
| 17 Dec 1997 | K973594 | GORE RESOLUT XT REGENERATIVE MATERIAL | LYC Synthetic Bone Grafting Material |
| 8 May 1997 | K970884 | RESOLUT REGENERATIVE MATERIAL | LYC Synthetic Bone Grafting Material |
| 3 Oct 1996 | K962624 | RESOLUT REGENERATIVE MATERIAL | LYC Synthetic Bone Grafting Material |
| 15 Apr 1996 | K960292 | GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS | NPK Intraoral Synthetic Barrier |
| 28 Mar 1995 | K932866 | RESOLUT REGENERATIVE MATERIAL | LYC Synthetic Bone Grafting Material |
| 10 Jun 1994 | K922627 | GORE-TEX REGENERATIVE MATERIAL | NPK Intraoral Synthetic Barrier |
| 30 Nov 1993 | K933541 | GORE-TEX PERIODONTAL MATERIAL - TITANIUM REINFORCED CONFIGURATIONS | NPK Intraoral Synthetic Barrier |
| 30 Sep 1991 | K910427 | MEMFIX SCREWS | DZL Intraosseous Fixation Screw |
| 19 May 1986 | K854299 | GORE-TEX PERIODONTAL MATERIAL | NPK Intraoral Synthetic Barrier |
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.