Degussa Corp.: FDA clearances and approvals
Degussa Corp. has 24 FDA 510(k) clearances (first 1995, latest 1997), across 3 product codes in 1 review panel. Median 510(k) review time: 49 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 |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | 22 | 22 |
| EJS | Alloy, Other Noble Metal | 1 | 1 |
| ELW | Material, Impression | 1 | 1 |
Review panels
- Dental (24)
Most recent Degussa Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973288 | STABILOR HN | EJS | 1997-11-19 | 78 |
| K972910 | PORS ON LITE | EJT | 1997-10-14 | 68 |
| K960256 | DEGUDENT LS | EJT | 1996-02-21 | 34 |
| K960226 | DG 88 | EJT | 1996-02-14 | 28 |
| K960104 | BIOCCLUS 4 | EJT | 1996-02-06 | 26 |
| K955465 | DEGUPRINT | ELW | 1995-12-28 | 28 |
| K955118 | DEGUBOND X-LITE PLUS | EJT | 1995-12-11 | 32 |
| K955027 | DEGUBOND X-LITE | EJT | 1995-12-01 | 29 |
| K951789 | PALLIAG NF IV | EJT | 1995-06-14 | 58 |
| K951791 | DEPALOR | EJT | 1995-06-12 | 56 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Degussa Corp..
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 Degussa Corp. have?
Degussa Corp. has 24 FDA 510(k) clearances (first 1995, latest 1997), across 3 product codes in 1 review panel.
How long does FDA take to clear Degussa Corp.'s 510(k)s?
The median time from FDA receipt to decision across Degussa Corp.'s cleared 510(k)s is 49 days.
What devices does Degussa Corp. make?
Its most frequent FDA product codes are EJT (Alloy, Gold-Based Noble Metal, 22); EJS (Alloy, Other Noble Metal, 1); ELW (Material, Impression, 1).
Has Degussa Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Degussa Corp. Related entities may recall under other names.
Next steps
- See all 24 Degussa Corp. clearances with predicates and recalls
- Run predicate analysis for product code EJT, Degussa Corp.'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.