Not currently registered with FDA under this name
Matech, Inc.
Sylmar, CA, United States. Named as applicant on 6 dental 510(k) clearances between 1994 and 2001. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 61994–2001
- Markets registered in
- 315 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 3 markets
Where regulators' registries name Matech, 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 | Matech, Inc. | 6 clearances | 1994–2001 | Below |
| South Korea | MFDS | Manufacturer | Matech, Inc.Matech,Inc. · MATECH, INC · +2 | 14 | 1999–2006 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MATECH INC. | 1 | 2008–2008 | 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 Matech, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 15 Feb 2001 | K010069 | DURABOND NON-PRECIOUS CERAMIC ALLOY | EJH Base Metal Alloy |
| 13 Dec 1999 | K993572 | CERADIUM V NON-PRECIOUS CERAMIC ALLOY | EJH Base Metal Alloy |
| 19 Nov 1999 | K992881 | HI BOND NON-PRECIOUS CERAMIC ALLOY | EJH Base Metal Alloy |
| 22 Sep 1999 | K992705 | CERADIUM NON-PRECIOUS CERAMIC ALLOY | EJH Base Metal Alloy |
| 12 Feb 1998 | K974894 | KROMATICA COLOR CHANGING ALGINATE | ELW Impression Material |
| 21 Jan 1994 | K925746 | REPLICA | ELW Impression Material |
Some of these clearances are listed with FDA today by another company: The Belport Company, Inc. DBA Gingi-Pak (6).
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.