Dreve Dentamid GmbH: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Dreve Dentamid GmbH” (first 2017, latest 2025), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 252 days. Since 2017 the median was 252 days, against 126 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2017 | 1 | 184 |
| 2018 | 2 | 451 |
| 2019 | 1 | 246 |
| 2020 | 1 | 259 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 241 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Dreve Dentamid GmbH took a median 252 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ELW | Material, Impression | 2 | 2 |
| EBD | Coating, Filling Material, Resin | 1 | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| NXC | Aligner, Sequential | 1 | 1 |
Review panels
- Dental (6)
Most recent Dreve Dentamid GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250739 | Primeprint Direct Aligner | NXC | 2025-11-07 | 241 |
| K200580 | FotoDent denture | EBI | 2020-11-19 | 259 |
| K190571 | StoneBite and StoneBite scan | ELW | 2019-11-07 | 246 |
| K171562 | Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono | ELW | 2018-04-13 | 318 |
| K162408 | Nano Varnish, Plaquit, Lightpaint on Surface | EBD | 2018-04-05 | 584 |
| K171729 | Fixtemp C&B | EBG | 2017-12-13 | 184 |
Recalls
openFDA lists no recalls under a recalling firm named Dreve Dentamid GmbH.
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.
- Dreve Denatmid GmbH (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dreve Dentamid GmbH?
FDA lists 6 510(k) clearances under the applicant name “Dreve Dentamid GmbH” (first 2017, latest 2025), across 5 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 Dreve Dentamid GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dreve Dentamid GmbH is 252 days. Since 2017: 252 days, versus 126 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Dreve Dentamid GmbH?
The most frequent FDA product codes under this applicant name are ELW (Material, Impression, 2); EBD (Coating, Filling Material, Resin, 1); EBG (Crown And Bridge, Temporary, Resin, 1).
Next steps
- See all 6 Dreve Dentamid GmbH clearances with predicates and recalls
- Run predicate analysis for product code ELW, Dreve Dentamid GmbH'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.