Not currently registered with FDA under this name
Gateway Alloys, Inc.
St. Charles, MO, United States. Named as applicant on 31 dental 510(k) clearances between 1996 and 2001. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 311996–2001
- Markets registered in
- 21 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Gateway Alloys, 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 | Gateway Alloys, Inc. | 31 clearances | 1996–2001 | Below |
| Israel | AMAR | Manufacturer | GATEWAY ALLOYS 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 Gateway Alloys, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 27 Aug 2001 | K011661 | CONCORD 88 | EJT Gold-Based Noble Metal Alloy |
| 27 Aug 2001 | K011659 | GPW-SF | EJT Gold-Based Noble Metal Alloy |
| 16 Jul 2001 | K011628 | CONCORD 82 | EJT Gold-Based Noble Metal Alloy |
| 16 Jul 2001 | K011626 | CONCORD 72 | EJT Gold-Based Noble Metal Alloy |
| 13 Jan 1997 | K964950 | LA PLATA 28 (PM-28) | EJT Gold-Based Noble Metal Alloy |
| 13 Jan 1997 | K964949 | AURORA 53 | EJT Gold-Based Noble Metal Alloy |
| 13 Jan 1997 | K964948 | AURORA 52 (PM-01) | EJT Gold-Based Noble Metal Alloy |
| 13 Jan 1997 | K964941 | EL DORADO 40 | EJT Gold-Based Noble Metal Alloy |
| 13 Jan 1997 | K964940 | TAOS 28 | EJT Gold-Based Noble Metal Alloy |
| 20 Dec 1996 | K964838 | PALLADIA 85 (PM-13) | EJT Gold-Based Noble Metal Alloy |
| 20 Dec 1996 | K964837 | PACIFIC 56 (CB-40) | EJT Gold-Based Noble Metal Alloy |
| 20 Dec 1996 | K964792 | LA PLATA 40 | EJT Gold-Based Noble Metal Alloy |
| 20 Dec 1996 | K964789 | LA PLATA 39 | EJT Gold-Based Noble Metal Alloy |
| 20 Dec 1996 | K964788 | EL DORADO 55 | EJT Gold-Based Noble Metal Alloy |
| 16 Dec 1996 | K964713 | SOLDER GPW | EJS Alloy Other Noble Metal |
| 16 Dec 1996 | K964708 | SOLDER 615 | EJT Gold-Based Noble Metal Alloy |
| 16 Dec 1996 | K964707 | SOLDER 585 | EJS Alloy Other Noble Metal |
| 16 Dec 1996 | K964706 | SOLDER 650 | EJS Alloy Other Noble Metal |
| 16 Dec 1996 | K964705 | SOLDER GPY | EJS Alloy Other Noble Metal |
| 6 Dec 1996 | K964573 | PIEDMONT 70 (CH-35) | EJT Gold-Based Noble Metal Alloy |
| 6 Dec 1996 | K964572 | PALLADIA 76 | EJT Gold-Based Noble Metal Alloy |
| 6 Dec 1996 | K964569 | EL DORADO 58 | EJT Gold-Based Noble Metal Alloy |
| 6 Dec 1996 | K964568 | OZARK 46 | EJT Gold-Based Noble Metal Alloy |
| 6 Dec 1996 | K964567 | EL DORADO 75 | EJT Gold-Based Noble Metal Alloy |
| 6 Dec 1996 | K964566 | OZARK 20 | EJT Gold-Based Noble Metal Alloy |
| 4 Dec 1996 | K964476 | DE ORO 77 | EJT Gold-Based Noble Metal Alloy |
| 2 Dec 1996 | K964477 | OZARK 40 | EJT Gold-Based Noble Metal Alloy |
| 26 Nov 1996 | K964478 | OSAGE 76 | EJT Gold-Based Noble Metal Alloy |
| 26 Nov 1996 | K964465 | LA PLATA 34 (PM-25) | EJT Gold-Based Noble Metal Alloy |
| 26 Nov 1996 | K964464 | PACIFIC 52 (CB-39) | EJT Gold-Based Noble Metal Alloy |
| 20 Nov 1996 | K964466 | PALLADIA 75 (PM-11) | EJT Gold-Based Noble Metal Alloy |
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.