Jeneric Ind.: FDA clearances and approvals
Jeneric Ind. has 25 FDA 510(k) clearances (first 1982, latest 1986), across 7 product codes in 1 review panel. Median 510(k) review time: 55 days.
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 |
|---|---|---|---|
| EJH | Alloy, Metal, Base | 12 | 12 |
| EJS | Alloy, Other Noble Metal | 6 | 6 |
| EJT | Alloy, Gold-Based Noble Metal | 3 | 3 |
| EIH | Powder, Porcelain | 1 | 1 |
| EIS | Remover, Crown | 1 | 1 |
| EJJ | Alloy, Amalgam | 1 | 1 |
| ELE | Implant, Subperiosteal | 1 | 1 |
Review panels
- Dental (25)
Most recent Jeneric Ind. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K862822 | REXILLIUM N. B. F. | EJH | 1986-09-02 | 39 |
| K862926 | SURGICAL VITEX | ELE | 1986-08-29 | 28 |
| K854878 | H40 BASE METAL ALLOY | EJH | 1986-01-30 | 55 |
| K844123 | RX CBY | EJH | 1985-01-09 | 78 |
| K844122 | RX CBG | EJH | 1985-01-09 | 78 |
| K840563 | RX C & B 20 | EJS | 1984-05-01 | 83 |
| K840561 | RX ELAN | EJS | 1984-05-01 | 83 |
| K840562 | REX V | EJH | 1984-04-13 | 65 |
| K834560 | VITEX P.D.A | EJH | 1984-02-27 | 61 |
| K833774 | NATURELLE II & LITE II-N72-N74-L | EJS | 1984-01-24 | 89 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Jeneric Ind..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Jeneric Ind. have?
Jeneric Ind. has 25 FDA 510(k) clearances (first 1982, latest 1986), across 7 product codes in 1 review panel.
How long does FDA take to clear Jeneric Ind.'s 510(k)s?
The median time from FDA receipt to decision across Jeneric Ind.'s cleared 510(k)s is 55 days.
What devices does Jeneric Ind. make?
Its most frequent FDA product codes are EJH (Alloy, Metal, Base, 12); EJS (Alloy, Other Noble Metal, 6); EJT (Alloy, Gold-Based Noble Metal, 3).
Has Jeneric Ind. had device recalls?
openFDA lists no recalls under a recalling firm name matching Jeneric Ind. Related entities may recall under other names.
Next steps
- See all 25 Jeneric Ind. clearances with predicates and recalls
- Run predicate analysis for product code EJH, Jeneric Ind.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.