Degussa AG: FDA filings under this applicant name
FDA lists 33 510(k) clearances under the applicant name “Degussa AG” (first 1990, latest 1995), across 14 product codes in 1 review panel. Median 510(k) review time under this name: 63 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 6 | 6 |
| EJT | Alloy, Gold-Based Noble Metal | 4 | 4 |
| EFD | Amalgamator, Dental, Ac-Powered | 3 | 3 |
| EJJ | Alloy, Amalgam | 3 | 3 |
| EJS | Alloy, Other Noble Metal | 3 | 3 |
| ELW | Material, Impression | 3 | 3 |
| KLE | Agent, Tooth Bonding, Resin | 3 | 3 |
| EJH | Alloy, Metal, Base | 2 | 2 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| EIH | Powder, Porcelain | 1 | 1 |
Plus 4 more product codes.
Review panels
- Dental (33)
Most recent Degussa AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953344 | DEGUBOND ULTRA | EJT | 1995-08-25 | 44 |
| K931808 | DUCERAGOLD, DUCERATIN | ELL | 1993-11-03 | 205 |
| K926347 | DUCERANIUM U | EJH | 1993-05-27 | 161 |
| K922790 | DEGUCAST 40 | EJH | 1992-12-03 | 177 |
| K921772 | BIOLOR | EJT | 1992-07-13 | 90 |
| K921479 | DUCERATIN/DUCERAM LFC DENTAL PORCELAIN | EIH | 1992-06-22 | 84 |
| K921445 | DEGUBOND PLUS | EJS | 1992-05-26 | 62 |
| K921419 | DEVA PLUS | EJS | 1992-05-26 | 63 |
| K914368 | PART 872 DEGUFILL H & DEGUFILL M DA | EKJ | 1991-11-13 | 43 |
| K914341 | MIXOMAT AMALGAMATOR | EFD | 1991-11-13 | 47 |
23 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Degussa AG.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Degussa Dental, Inc. (25 510(k)s)
- Degussa Corp. (24 510(k)s)
- Degussa - Ney Dental, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Degussa AG?
FDA lists 33 510(k) clearances under the applicant name “Degussa AG” (first 1990, latest 1995), across 14 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 Degussa AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Degussa AG is 63 days.
Which FDA product codes appear under Degussa AG?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 6); EJT (Alloy, Gold-Based Noble Metal, 4); EFD (Amalgamator, Dental, Ac-Powered, 3).
Next steps
- See all 33 Degussa AG clearances with predicates and recalls
- Run predicate analysis for product code EBF, Degussa AG'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.