Deltamed GmbH: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Deltamed GmbH” (first 2011, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 149 days. Since 2017 the median was 151 days, against 115 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 205 |
| 2021 | 1 | 178 |
| 2022 | 1 | 151 |
| 2023 | 1 | 57 |
| 2024 | 1 | 15 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Deltamed GmbH took a median 151 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 2 | 2 |
| EBG | Crown And Bridge, Temporary, Resin | 2 | 2 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | 2 |
Review panels
- Dental (6)
Most recent Deltamed GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243720 | 3Delta UNlimited | EBF | 2024-12-18 | 15 |
| K230341 | ACRIFIX | EBI | 2023-04-06 | 57 |
| K212541 | 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix | EBI | 2022-01-10 | 151 |
| K211804 | 3Delta Crown | EBF | 2021-12-06 | 178 |
| K200039 | P pro Crown & Bridge | EBG | 2020-07-31 | 205 |
| K102776 | EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM | EBG | 2011-02-18 | 147 |
Recalls
openFDA lists no recalls under a recalling firm named Deltamed 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Deltamed GmbH?
FDA lists 6 510(k) clearances under the applicant name “Deltamed GmbH” (first 2011, latest 2024), across 3 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 Deltamed GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Deltamed GmbH is 149 days. Since 2017: 151 days, versus 115 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Deltamed GmbH?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 2); EBG (Crown And Bridge, Temporary, Resin, 2); EBI (Resin, Denture, Relining, Repairing, Rebasing, 2).
Next steps
- See all 6 Deltamed GmbH clearances with predicates and recalls
- Run predicate analysis for product code EBF, Deltamed 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.