European Dental Imports, Inc.: FDA clearances and approvals
European Dental Imports, Inc. has 7 FDA 510(k) clearances (first 1998, latest 1998), across 3 product codes in 1 review panel. Median 510(k) review time: 61 days.
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 |
|---|---|---|---|
| EJS | Alloy, Other Noble Metal | 3 | 3 |
| EIH | Powder, Porcelain | 2 | 2 |
| EJT | Alloy, Gold-Based Noble Metal | 2 | 2 |
Review panels
- Dental (7)
Most recent European Dental Imports, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982129 | ANTAGON PORCELAIN | EIH | 1998-08-04 | 48 |
| K981002 | ORION WX DENTAL ALLOY | EJS | 1998-05-18 | 61 |
| K981001 | ORION VESTA DENTAL ALLOY | EJS | 1998-05-18 | 61 |
| K981000 | CARRARA PORCELAIN AND CARRARA VINCENT PORCELAIN | EIH | 1998-05-15 | 58 |
| K980661 | CERA E DENTAL ALLOY | EJS | 1998-05-01 | 70 |
| K980660 | BIOGOLD PLUS DENTAL ALLOY | EJT | 1998-04-27 | 66 |
| K980597 | CARRARA PDF, CARRARA H, CARRARA R | EJT | 1998-03-09 | 20 |
Recalls
openFDA lists no recalls under a recalling firm named European Dental Imports, 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 European Dental Imports, Inc. have?
European Dental Imports, Inc. has 7 FDA 510(k) clearances (first 1998, latest 1998), across 3 product codes in 1 review panel.
How long does FDA take to clear European Dental Imports, Inc.'s 510(k)s?
The median time from FDA receipt to decision across European Dental Imports, Inc.'s cleared 510(k)s is 61 days.
What devices does European Dental Imports, Inc. make?
Its most frequent FDA product codes are EJS (Alloy, Other Noble Metal, 3); EIH (Powder, Porcelain, 2); EJT (Alloy, Gold-Based Noble Metal, 2).
Has European Dental Imports, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching European Dental Imports, Inc. Related entities may recall under other names.
Next steps
- See all 7 European Dental Imports, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EJS, European Dental Imports, 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.