FirmLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Highland Metals, Inc. with 7 510(k) clearances and 2 device recalls. The most recent is a device recall dated Dec 13, 2013: SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 cou….
| Dec 13, 2013 | SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA Class II · Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lo | Device recalls |
| Dec 13, 2013 | SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA Class II · Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lo | Device recalls |
| May 18, 1994 | NITINOL, NITIK935638 · DZC | 510(k) clearances |
| Nov 19, 1993 | NITI COIL SPRINGSK933374 · DZC | 510(k) clearances |
| Nov 16, 1993 | STAINLESS STEEL ARCHES REPACKER RELABETERK933377 · DZC | 510(k) clearances |
| Nov 12, 1993 | REVERSE CURVE NITI ARCH WIRE REPACKER RELABETERK933378 · DZC | 510(k) clearances |
| Nov 12, 1993 | STAINLESS STEEL ARCHESK933379 · DZC | 510(k) clearances |
| Nov 12, 1993 | NITI ARCH WIRE ON A SPOOLK933376 · DZC | 510(k) clearances |
| Nov 12, 1993 | REVERSE SURVE NITI ARCH WIREK933380 · DZC | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
