Deldent , Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Deldent , Ltd.” (first 2001, latest 2002), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 44 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 |
|---|---|---|---|
| KOJ | Airbrush | 4 | 4 |
| ELC | Scaler, Ultrasonic | 2 | 2 |
Review panels
- Dental (6)
Most recent Deldent , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K014252 | JETSTREAM | KOJ | 2002-02-19 | 55 |
| K014249 | JETPOLISHER | KOJ | 2002-02-19 | 55 |
| K014245 | JETSONIC 2000 | KOJ | 2002-01-29 | 34 |
| K014238 | DELSONIC 2000 | ELC | 2002-01-24 | 29 |
| K013969 | MINIBLASTER | KOJ | 2002-01-10 | 38 |
| K011179 | DELDENT ULTRASONIC INSERTS | ELC | 2001-06-05 | 49 |
Recalls
openFDA lists no recalls under a recalling firm named Deldent , Ltd..
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 Deldent , Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Deldent , Ltd.” (first 2001, latest 2002), across 2 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 Deldent , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Deldent , Ltd. is 44 days.
Which FDA product codes appear under Deldent , Ltd.?
The most frequent FDA product codes under this applicant name are KOJ (Airbrush, 4); ELC (Scaler, Ultrasonic, 2).
Next steps
- See all 6 Deldent , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KOJ, Deldent , Ltd.'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.