Deringer-Ney, Inc.: FDA filings under this applicant name
FDA lists 46 510(k) clearances under the applicant name “Deringer-Ney, Inc.” (first 1976, latest 1993), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 51 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 | 22 | 22 |
| EJS | Alloy, Other Noble Metal | 14 | 14 |
| EJH | Alloy, Metal, Base | 2 | 2 |
| ECG | Sterilizer, Boiling Water | 1 | 1 |
| ELL | Teeth, Porcelain | 1 | 1 |
| EMD | Hemostat, Surgical | 1 | 1 |
| KXR | Applicator, Resin | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (42)
Most recent Deringer-Ney, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K933178 | GDC 3509 | EJT | 1993-10-14 | 106 |
| K930482 | DENTAL CASTING ALLOY, MODIFICATION - PF-3 | EJT | 1993-03-31 | 61 |
| K930481 | DENTAL CASTING ALLOY MODIFICATION-PF-4 | EJT | 1993-03-31 | 61 |
| K925273 | GDC 3445 | EJS | 1992-12-21 | 63 |
| K920922 | GDC 3367 | EJS | 1992-05-05 | 67 |
| K920060 | DENTAL SOLDER ALLOY | EJT | 1992-04-02 | 87 |
| K920887 | GDC-3338, DENTAL SOLDER ALLOY | EJS | 1992-03-19 | 77 |
| K910065 | GDC-3200 DENTAL SOLDER | EJT | 1991-03-15 | 65 |
| K904695 | GDC-1501 | EJT | 1991-01-02 | 78 |
| K904614 | GDC-1475 | EJT | 1990-12-19 | 69 |
36 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Deringer-Ney, 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 Deringer-Ney, Inc.?
FDA lists 46 510(k) clearances under the applicant name “Deringer-Ney, Inc.” (first 1976, latest 1993), 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 Deringer-Ney, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Deringer-Ney, Inc. is 51 days.
Which FDA product codes appear under Deringer-Ney, Inc.?
The most frequent FDA product codes under this applicant name are EJT (Alloy, Gold-Based Noble Metal, 22); EJS (Alloy, Other Noble Metal, 14); EJH (Alloy, Metal, Base, 2).
Next steps
- See all 46 Deringer-Ney, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EJT, Deringer-Ney, 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.