E&D Dental Manufacturing Co.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “E&D Dental Manufacturing Co.” (first 1986, latest 1988), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 66 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 |
|---|---|---|---|
| DZP | Instrument, Diamond, Dental | 1 | 1 |
| EBH | Material, Impression Tray, Resin | 1 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| EKS | File, Pulp Canal, Endodontic | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
| EMB | Zinc Oxide Eugenol | 1 | 1 |
Review panels
- Dental (6)
Most recent E&D Dental Manufacturing Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K883698 | ZINC OXIDE EUGENOL TEMPORARY CEMENT | EMA | 1988-11-29 | 91 |
| K873739 | ACRYLIC IMPRESSION TRAY MATERIALS | EBH | 1988-03-07 | 174 |
| K873738 | ACRYLIC BASE DENTURE MATERIALS | EBI | 1987-11-20 | 66 |
| K871639 | DENTAL DIAMOND BURS | DZP | 1987-05-18 | 21 |
| K864922 | DENTAL HANDPIECES AND ATTACHMENT | EKS | 1987-02-19 | 65 |
| K862745 | EUGENOL USP | EMB | 1986-07-31 | 10 |
Recalls
openFDA lists no recalls under a recalling firm named E&D Dental Manufacturing Co..
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 E&D Dental Manufacturing Co.?
FDA lists 6 510(k) clearances under the applicant name “E&D Dental Manufacturing Co.” (first 1986, latest 1988), across 6 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 E&D Dental Manufacturing Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name E&D Dental Manufacturing Co. is 66 days.
Which FDA product codes appear under E&D Dental Manufacturing Co.?
The most frequent FDA product codes under this applicant name are DZP (Instrument, Diamond, Dental, 1); EBH (Material, Impression Tray, Resin, 1); EBI (Resin, Denture, Relining, Repairing, Rebasing, 1).
Next steps
- See all 6 E&D Dental Manufacturing Co. clearances with predicates and recalls
- Run predicate analysis for product code DZP, E&D Dental Manufacturing Co.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.