Highland Metals: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Highland Metals” (first 1993, latest 1994), across 1 product code in 1 review panel. Median 510(k) review time under this name: 126 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZC | Wire, Orthodontic | 7 | 7 |
Review panels
- Dental (7)
Most recent Highland Metals 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K935638 | NITINOL, NITI | DZC | 1994-05-18 | 176 |
| K933374 | NITI COIL SPRINGS | DZC | 1993-11-19 | 133 |
| K933377 | STAINLESS STEEL ARCHES REPACKER RELABETER | DZC | 1993-11-16 | 130 |
| K933380 | REVERSE SURVE NITI ARCH WIRE | DZC | 1993-11-12 | 126 |
| K933379 | STAINLESS STEEL ARCHES | DZC | 1993-11-12 | 126 |
| K933378 | REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER | DZC | 1993-11-12 | 126 |
| K933376 | NITI ARCH WIRE ON A SPOOL | DZC | 1993-11-12 | 126 |
Recalls
7 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2013-12-13.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Highland / Marietta, Inc. (2 510(k)s)
- Highland Instruments (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Highland Metals?
FDA lists 7 510(k) clearances under the applicant name “Highland Metals” (first 1993, latest 1994), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Highland Metals?
The median time from FDA receipt to decision across 510(k)s cleared under the name Highland Metals is 126 days.
Which FDA product codes appear under Highland Metals?
The most frequent FDA product codes under this applicant name are DZC (Wire, Orthodontic, 7).
Next steps
- See all 7 Highland Metals clearances with predicates and recalls
- Run predicate analysis for product code DZC, Highland Metals's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.