J.F. Jelenko & Co., Inc.: FDA filings under this applicant name
FDA lists 56 510(k) clearances under the applicant name “J.F. Jelenko & Co., Inc.” (first 1988, latest 2001), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 62 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 |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | 38 | 38 |
| EJS | Alloy, Other Noble Metal | 11 | 11 |
| EIH | Powder, Porcelain | 2 | 2 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| EJJ | Alloy, Amalgam | 1 | 1 |
| ELM | Denture, Plastic, Teeth | 1 | 1 |
Review panels
- Dental (56)
Most recent J.F. Jelenko & Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012303 | JEL-20 | EJS | 2001-08-22 | 33 |
| K002993 | HERACERAM | EIH | 2000-11-16 | 52 |
| K002645 | JEL BIOS PURE | EJT | 2000-10-19 | 56 |
| K002222 | RD-2104 | EJT | 2000-08-31 | 38 |
| K001360 | SIGNUM | EBF | 2000-06-20 | 53 |
| K001260 | ALLROUND 55 LF | EJT | 2000-05-17 | 28 |
| K001196 | JEL BIOS 90 (CODE NAME RD-2401) | EJT | 2000-05-11 | 29 |
| K000532 | JEL 15 | EJS | 2000-04-06 | 49 |
| K000213 | JELDENT BASIC LINE | ELM | 2000-04-06 | 73 |
| K993152 | JEL BIOS 18 (CODE NAME RD- 1214) | EJT | 1999-10-21 | 30 |
46 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named J.F. Jelenko & Co., Inc..
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 J.F. Jelenko & Co., Inc.?
FDA lists 56 510(k) clearances under the applicant name “J.F. Jelenko & Co., Inc.” (first 1988, latest 2001), across 8 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 J.F. Jelenko & Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name J.F. Jelenko & Co., Inc. is 62 days.
Which FDA product codes appear under J.F. Jelenko & Co., Inc.?
The most frequent FDA product codes under this applicant name are EJT (Alloy, Gold-Based Noble Metal, 38); EJS (Alloy, Other Noble Metal, 11); EIH (Powder, Porcelain, 2).
Next steps
- See all 56 J.F. Jelenko & Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code EJT, J.F. Jelenko & Co., Inc.'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.