Company ยท US
Highland Metals
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 1994. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 18, 1994 | K935638 | NITINOL, NITI Highland Metals | DZC |
| Nov 19, 1993 | K933374 | NITI COIL SPRINGS Highland Metals | DZC |
| Nov 16, 1993 | K933377 | STAINLESS STEEL ARCHES REPACKER RELABETER Highland Metals | DZC |
| Nov 12, 1993 | K933380 | REVERSE SURVE NITI ARCH WIRE Highland Metals | DZC |
| Nov 12, 1993 | K933379 | STAINLESS STEEL ARCHES Highland Metals | DZC |
| Nov 12, 1993 | K933378 | REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER Highland Metals | DZC |
| Nov 12, 1993 | K933376 | NITI ARCH WIRE ON A SPOOL Highland Metals | DZC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2014 | Highland Metals, Inc. SuperElastic Regular force NiTi lower or upper Natural arches.
0.14 size
10 or 100 count packages.
Highland Metals Inc.
San Jose, CA
The devices are intended to provide force to the teeth to effect Terminated |
DZC | None listed |
| Feb 3, 2014 | Highland Metals, Inc. SuperElastic Regular force NiTi lower or upper Natural arches.
0.16 size
10 or 100 count packages.
Highland Metals Inc.
San Jose, CA
The devices are intended to provide force to the teeth to effect Terminated |
DZC | None listed |
| Aug 9, 2011 | Highland Metals Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires.
Packaged in 19 packages of 100 and 6 packages of 10.
Highland Metals, Inc.
Wire used for orthodontic treatment to place in the brack Terminated |
D | None listed |
| Jul 7, 2011 | Highland Metals Stainless Steel, Natural, Lower, .018": Arch Wires.
Highland Metals, San Jose, CA 95125 Terminated |
D | None listed |
| Jul 7, 2011 | Highland Metals Stainless Steel, Natural, Upper, .018": Arch Wires.
Highland Metals, San Jose, CA 95125 Terminated |
D | None listed |
| Jul 7, 2011 | Highland Metals Stainless Steel, Natural,Lower, .016 x.022: Arch Wires.
Highland Metals, San Jose, CA 95125 Terminated |
D | None listed |
| Jul 7, 2011 | Highland Metals Stainless Steel, Progressive Lower, .016: Arch Wires.
Intended for use in orthodontic treatment Terminated |
D | None listed |