Jelenko Co.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Jelenko Co.” (first 1988, latest 2001), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 61 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 | 8 | 8 |
| EJS | Alloy, Other Noble Metal | 2 | 2 |
| EJH | Alloy, Metal, Base | 1 | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
Review panels
- Dental (12)
Most recent Jelenko Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K010416 | HERACERAM 75 | EJT | 2001-03-08 | 24 |
| K003603 | BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE | EJT | 2001-01-10 | 50 |
| K984164 | JELBOND NP | EJH | 1998-12-29 | 39 |
| K964158 | JEL-40 (CODE NAME RD-0430) | EJT | 1996-12-13 | 58 |
| K930762 | SUPERSTAR | EJT | 1993-03-31 | 47 |
| K912195 | PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE | EJS | 1991-07-30 | 74 |
| K912194 | PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE | EJS | 1991-07-30 | 74 |
| K896915 | PALLADIUM BASED DENTAL ALLOY FOR PORCELAIN-METAL | EJT | 1990-04-30 | 140 |
| K894391 | PVS DUAL CURE VENEER BONDING KIT | KLE | 1989-09-19 | 64 |
| K893688 | HIGH NOBLE, TYPE III DENTAL CASTING ALLOY | EJT | 1989-08-23 | 99 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Jelenko Co..
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 Jelenko Co.?
FDA lists 12 510(k) clearances under the applicant name “Jelenko Co.” (first 1988, latest 2001), across 4 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 Jelenko Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Jelenko Co. is 61 days.
Which FDA product codes appear under Jelenko Co.?
The most frequent FDA product codes under this applicant name are EJT (Alloy, Gold-Based Noble Metal, 8); EJS (Alloy, Other Noble Metal, 2); EJH (Alloy, Metal, Base, 1).
Next steps
- See all 12 Jelenko Co. clearances with predicates and recalls
- Run predicate analysis for product code EJT, Jelenko Co.'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.