Leach and Dillon Co., Inc.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Leach and Dillon Co., Inc.” (first 1989, latest 1991), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 132 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 | 27 | 27 |
| EIH | Powder, Porcelain | 2 | 2 |
| EJH | Alloy, Metal, Base | 2 | 2 |
Review panels
- Dental (31)
Most recent Leach and Dillon Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K903538 | WIRON 99 DENTAL CASTING ALLOY | EJH | 1991-03-15 | 220 |
| K903537 | 250 SL DENTAL CASTING ALLOY | EJT | 1990-10-24 | 78 |
| K895059 | HIGH FUSING YELLOW CERAMIC SOLDER | EJT | 1990-10-05 | 423 |
| K895058 | HIGH FUSING WHITE CERAMIC SOLDER | EJT | 1990-10-05 | 423 |
| K903484 | SELECT 20, DENTAL ALLOY | EJT | 1990-09-14 | 45 |
| K902373 | 200 SILHOUETTE LINE (SL) CERAMIC SOLDER | EJT | 1990-06-28 | 30 |
| K902372 | SILVER-FREE CERAMIC SOLDER (SFCS) | EJT | 1990-06-28 | 30 |
| K895888 | SILHOUETTE PORCELAIN | EIH | 1990-04-10 | 187 |
| K895889 | SHAKE N' SPRAY (W/SILHOUETTE PORCELAIN) | EIH | 1990-04-04 | 181 |
| K895066 | MONOGRAM IV | EJT | 1990-02-14 | 190 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Leach and Dillon Co., 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 Leach and Dillon Co., Inc.?
FDA lists 31 510(k) clearances under the applicant name “Leach and Dillon Co., Inc.” (first 1989, latest 1991), across 3 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 Leach and Dillon Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Leach and Dillon Co., Inc. is 132 days.
Which FDA product codes appear under Leach and Dillon Co., Inc.?
The most frequent FDA product codes under this applicant name are EJT (Alloy, Gold-Based Noble Metal, 27); EIH (Powder, Porcelain, 2); EJH (Alloy, Metal, Base, 2).
Next steps
- See all 31 Leach and Dillon Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code EJT, Leach and Dillon Co., 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.