Highland Metals
Medical device manufacturer in San Jose, CA.
7510(k) clearances
0PMA approvals
7recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K935638 | Nitinol, NitiDZC · Traditional | 05/18/1994SE |
| K933374 | Niti Coil SpringsDZC · Traditional | 11/19/1993SE |
| K933377 | Stainless Steel Arches Repacker RelabeterDZC · Traditional | 11/16/1993SE |
| K933380 | Reverse Surve Niti Arch WireDZC · Traditional | 11/12/1993SE |
| K933379 | Stainless Steel ArchesDZC · Traditional | 11/12/1993SE |
| K933378 | Reverse Curve Niti Arch Wire Repacker RelabeterDZC · Traditional | 11/12/1993SE |
| K933376 | Niti Arch Wire on a SpoolDZC · Traditional | 11/12/1993SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0923-2014 Class II | SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count…Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product… | 12/13/2013Terminated |
| Z-0922-2014 Class II | SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count…Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product… | 12/13/2013Terminated |
| Z-2963-2011 | Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires. Packaged in 19…Heat Activated Niti, Natural, Upper, .019 x 25" Arch wires mixed with size 021x0.25" Arch Wires. | 07/12/2011Terminated |
| Z-2730-2011 | Stainless Steel, Natural, Lower, .018": Arch Wires. Highland Metals, San Jose, CA 95125Boxes of stainless steel orthodontic wires were mislabeled with the incorrect size. | 01/07/2008Terminated |
| Z-2729-2011 | Stainless Steel, Natural, Upper, .018": Arch Wires. Highland Metals, San Jose, CA 95125Boxes of stainless steel orthodontic wires were mislabeled with the incorrect size. | 01/07/2008Terminated |
| Z-2728-2011 | Stainless Steel, Natural,Lower, .016 x.022: Arch Wires. Highland Metals, San Jose, CA…Boxes of stainless steel orthodontic wires were mislabeled with the incorrect size. | 01/07/2008Terminated |
| Z-2727-2011 | Stainless Steel, Progressive Lower, .016: Arch Wires. Intended for use in orthodontic…Boxes of stainless steel orthodontic wires were mislabeled as size.018" | 01/07/2008Terminated |