Not currently registered with FDA under this name
Highland Metals
San Jose, CA, United States. Named as applicant on 7 dental 510(k) clearances between 1993 and 1994. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 71993–1994
- Markets registered in
- 795 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 7 markets
Where regulators' registries name Highland Metals 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 | Highland Metals | 7 clearances | 1993–1994 | Below |
| Canada | Health Canada | Registration holder | HIGHLAND METALS INC | 83 | 2004–2009 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | HIGHLAND METALS INCHIGHLAND METALS INC. | 5 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | HIGHLAND METALS INC. | 3 | 2013–2013 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | HIGHLAND METALS INC. | 2 | 2006–2018 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | HIGHLAND METALS INC | 1 | 2021–2021 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Highland Metals Inc. | 1 | 2003–2003 | 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 Highland Metals as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 18 May 1994 | K935638 | NITINOL, NITI | DZC Orthodontic Wire |
| 19 Nov 1993 | K933374 | NITI COIL SPRINGS | DZC Orthodontic Wire |
| 16 Nov 1993 | K933377 | STAINLESS STEEL ARCHES REPACKER RELABETER | DZC Orthodontic Wire |
| 12 Nov 1993 | K933380 | REVERSE SURVE NITI ARCH WIRE | DZC Orthodontic Wire |
| 12 Nov 1993 | K933379 | STAINLESS STEEL ARCHES | DZC Orthodontic Wire |
| 12 Nov 1993 | K933378 | REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER | DZC Orthodontic Wire |
| 12 Nov 1993 | K933376 | NITI ARCH WIRE ON A SPOOL | DZC Orthodontic Wire |
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.