Jeneric/Pentron, Inc.: FDA clearances and approvals
Jeneric/Pentron, Inc. has 78 FDA 510(k) clearances (first 1988, latest 2002), across 20 product codes in 2 review panels. Median 510(k) review time: 62 days. openFDA lists 1 product recall by a recalling firm named Jeneric/Pentron, Inc.
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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 15 | 15 |
| EJT | Alloy, Gold-Based Noble Metal | 13 | 13 |
| EJS | Alloy, Other Noble Metal | 10 | 10 |
| KLE | Agent, Tooth Bonding, Resin | 9 | 9 |
| EJH | Alloy, Metal, Base | 6 | 6 |
| EIH | Powder, Porcelain | 5 | 5 |
| ELW | Material, Impression | 4 | 4 |
| EJJ | Alloy, Amalgam | 3 | 3 |
| ELL | Teeth, Porcelain | 2 | 2 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 1 | 1 |
Plus 10 more product codes.
Review panels
- Dental (77)
- Anesthesiology (1)
Most recent Jeneric/Pentron, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K020499 | BOND-3 ADHESIVE | KLE | 2002-04-22 | 67 |
| K013543 | BOND-1 C & B | KLE | 2002-02-22 | 128 |
| K013542 | DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1) | KLE | 2002-02-14 | 120 |
| K012231 | AVANTE MICRO CRYSTAL SYSTEM | EIH | 2001-08-23 | 38 |
| K011748 | FIRST FILL R.C.S. | KIF | 2001-08-03 | 58 |
| K010957 | QUELL DESENSITIZER | LBH | 2001-06-25 | 87 |
| K011331 | JP CAST 40 | EJT | 2001-06-22 | 51 |
| K011330 | JP CAST 50 | EJT | 2001-06-22 | 51 |
| K011362 | GOLD CORE 73 LS | EJT | 2001-05-29 | 26 |
| K010044 | COSMIC | EJT | 2001-02-09 | 35 |
68 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2009-10-22.
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/Pentron, Inc. have?
Jeneric/Pentron, Inc. has 78 FDA 510(k) clearances (first 1988, latest 2002), across 20 product codes in 2 review panels.
How long does FDA take to clear Jeneric/Pentron, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Jeneric/Pentron, Inc.'s cleared 510(k)s is 62 days.
What devices does Jeneric/Pentron, Inc. make?
Its most frequent FDA product codes are EBF (Material, Tooth Shade, Resin, 15); EJT (Alloy, Gold-Based Noble Metal, 13); EJS (Alloy, Other Noble Metal, 10).
Has Jeneric/Pentron, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Jeneric/Pentron, Inc; the most recent began 2009-10-22. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 78 Jeneric/Pentron, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Jeneric/Pentron, 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.