Degussa Dental, Inc.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Degussa Dental, Inc.” (first 1977, latest 1988), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 29 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 |
|---|---|---|---|
| EJS | Alloy, Other Noble Metal | 10 | 10 |
| EJT | Alloy, Gold-Based Noble Metal | 7 | 7 |
| EJH | Alloy, Metal, Base | 3 | 3 |
| EBF | Material, Tooth Shade, Resin | 2 | 2 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
| EJJ | Alloy, Amalgam | 1 | 1 |
| ELL | Teeth, Porcelain | 1 | 1 |
Review panels
- Dental (25)
Most recent Degussa Dental, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K883758 | ALBABOND 60 | EJT | 1988-10-12 | 36 |
| K883511 | ALBABOND E | EJS | 1988-10-06 | 50 |
| K883509 | HERAEUS DG 63 | EJS | 1988-09-22 | 36 |
| K883508 | HERA H | EJT | 1988-09-22 | 36 |
| K883510 | DEGUPAL 4 | EJS | 1988-09-15 | 29 |
| K883507 | HERAEUS C SPECIAL | EJS | 1988-09-15 | 29 |
| K883512 | HERAEUS WHITE | EJS | 1988-09-06 | 20 |
| K883036 | PALLIAG NF III | EJT | 1988-08-12 | 24 |
| K880033 | DEGUSTAR | EJT | 1988-03-07 | 62 |
| K871808 | DUCERAM-METAL-CERAMIC DENTAL PORCELAIN SYSTEM | ELL | 1987-06-05 | 28 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Degussa Dental, 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.
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 AG (33 510(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 Dental, Inc.?
FDA lists 25 510(k) clearances under the applicant name “Degussa Dental, Inc.” (first 1977, latest 1988), across 7 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 Dental, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Degussa Dental, Inc. is 29 days.
Which FDA product codes appear under Degussa Dental, Inc.?
The most frequent FDA product codes under this applicant name are EJS (Alloy, Other Noble Metal, 10); EJT (Alloy, Gold-Based Noble Metal, 7); EJH (Alloy, Metal, Base, 3).
Next steps
- See all 25 Degussa Dental, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EJS, Degussa Dental, 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 (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.