Unitek Corp.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Unitek Corp.” (first 1980, latest 1994), across 13 product codes in 1 review panel. Median 510(k) review time under this name: 66 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 |
|---|---|---|---|
| EJF | Bracket, Metal, Orthodontic | 4 | 4 |
| EJS | Alloy, Other Noble Metal | 3 | 3 |
| JEX | Plier, Orthodontic | 3 | 3 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 2 | 2 |
| DYW | Bracket, Plastic, Orthodontic | 2 | 2 |
| ECI | Band, Elastic, Orthodontic | 2 | 2 |
| DYN | Mouthpiece, Saliva Ejector | 1 | 1 |
| DYT | Maintainer, Space Preformed, Orthodontic | 1 | 1 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
| EID | Syringe, Restorative And Impression Material | 1 | 1 |
Plus 3 more product codes.
Review panels
- Dental (23)
Most recent Unitek Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K944286 | METAL-LINED TRANSCEND CERAMIC BRACKET | DYW | 1994-11-29 | 88 |
| K933501 | ALASTIK | EJF | 1994-04-28 | 283 |
| K940165 | ALASTIK | ECI | 1994-03-07 | 60 |
| K923999 | ALASTIK NS | ECI | 1993-06-24 | 318 |
| K924645 | TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS | JEX | 1992-11-25 | 72 |
| K924295 | DEBRACKETING INSTRUMENT | JEX | 1992-11-23 | 89 |
| K923432 | GERMAN MINI DYNALOCK | EJF | 1992-10-30 | 109 |
| K911271 | ADHESIVE PRECOATED BRACKETS | DYH | 1991-05-29 | 68 |
| K910288 | NONSTAINING ALASTIKS | EJF | 1991-03-29 | 66 |
| K890529 | ALASTIGARD | EJF | 1989-03-09 | 35 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Unitek Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Unitek Corp.?
FDA lists 23 510(k) clearances under the applicant name “Unitek Corp.” (first 1980, latest 1994), across 13 product codes 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 Unitek Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Unitek Corp. is 66 days.
Which FDA product codes appear under Unitek Corp.?
The most frequent FDA product codes under this applicant name are EJF (Bracket, Metal, Orthodontic, 4); EJS (Alloy, Other Noble Metal, 3); JEX (Plier, Orthodontic, 3).
Next steps
- See all 23 Unitek Corp. clearances with predicates and recalls
- Run predicate analysis for product code EJF, Unitek Corp.'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.