Jensen Industries, Inc.: FDA clearances and approvals
Jensen Industries, Inc. has 17 FDA 510(k) clearances (first 1998, latest 2019), across 3 product codes in 1 review panel. Median 510(k) review time: 54 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 143 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 100 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Jensen Industries, Inc.'s cleared 510(k)s took a median 100 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EIH | Powder, Porcelain | 11 | 11 |
| EJT | Alloy, Gold-Based Noble Metal | 5 | 5 |
| ELM | Denture, Plastic, Teeth | 1 | 1 |
Review panels
- Dental (17)
Most recent Jensen Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K183408 | Jensen Shade Effect Liquids | EIH | 2019-03-20 | 100 |
| K142043 | INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA | EIH | 2014-12-18 | 143 |
| K112806 | JENSEN ZIRCONIA | EIH | 2011-12-01 | 65 |
| K111743 | THE INSYNC CERAMIC SYSTEM | EIH | 2011-09-14 | 85 |
| K070114 | CREATION CP-ZI PORCELAIN | EIH | 2007-03-01 | 48 |
| K050838 | THE LF-P CERAMIC SYSTEM | EIH | 2005-05-04 | 33 |
| K043201 | WILLI GELLER CREATION ZI PORCELAIN | EIH | 2005-01-11 | 54 |
| K043221 | WILLI GELLER CREATION CP PORCELAIN | EIH | 2004-12-20 | 28 |
| K032267 | R&D DESIGNATION AP-052-5 | EJT | 2003-09-17 | 56 |
| K022206 | JENSEN GOLD FOIL | EJT | 2002-08-29 | 55 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Jensen Industries, Inc..
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 Jensen Industries, Inc. have?
Jensen Industries, Inc. has 17 FDA 510(k) clearances (first 1998, latest 2019), across 3 product codes in 1 review panel.
How long does FDA take to clear Jensen Industries, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Jensen Industries, Inc.'s cleared 510(k)s is 54 days.
What devices does Jensen Industries, Inc. make?
Its most frequent FDA product codes are EIH (Powder, Porcelain, 11); EJT (Alloy, Gold-Based Noble Metal, 5); ELM (Denture, Plastic, Teeth, 1).
Has Jensen Industries, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Jensen Industries, Inc. Related entities may recall under other names.
Next steps
- See all 17 Jensen Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EIH, Jensen Industries, Inc.'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.