Dental Direkt GmbH: FDA clearances and approvals
Dental Direkt GmbH has 9 FDA 510(k) clearances (first 2015, latest 2024), across 4 product codes in 1 review panel. Median 510(k) review time: 115 days. Since 2017 its median was 115 days, against 143 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 56 |
| 2016 | 1 | 161 |
| 2017 | 1 | 127 |
| 2018 | 0 | — |
| 2019 | 1 | 55 |
| 2020 | 1 | 115 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 3 | 128 |
| 2024 | 1 | 95 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Dental Direkt GmbH's cleared 510(k)s took a median 115 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 143 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EIH | Powder, Porcelain | 5 | 5 |
| NHA | Abutment, Implant, Dental, Endosseous | 2 | 2 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
Review panels
- Dental (9)
Most recent Dental Direkt GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241579 | DD Hybridlayer (multicolored zirconia) | EIH | 2024-09-06 | 95 |
| K230410 | DD medical polymers (PMMA) | EBI | 2023-06-23 | 128 |
| K230218 | DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) | NHA | 2023-04-25 | 89 |
| K191111 | DD Solid Connect® CAD/CAM Abutments | NHA | 2023-01-11 | 1356 |
| K193588 | DD Contrast | EIH | 2020-04-16 | 115 |
| K183569 | DD cube ONE ML | EIH | 2019-02-14 | 55 |
| K170885 | DD cubeX2 HS | EIH | 2017-08-01 | 127 |
| K153490 | DD medical polymers | EBG | 2016-05-13 | 161 |
| K150196 | DD cubeX2 | EIH | 2015-03-26 | 56 |
Recalls
openFDA lists no recalls under a recalling firm named Dental Direkt GmbH.
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 Dental Direkt GmbH have?
Dental Direkt GmbH has 9 FDA 510(k) clearances (first 2015, latest 2024), across 4 product codes in 1 review panel.
How long does FDA take to clear Dental Direkt GmbH's 510(k)s?
The median time from FDA receipt to decision across Dental Direkt GmbH's cleared 510(k)s is 115 days. Since 2017: 115 days, versus 143 days for all cleared 510(k)s in the same product codes.
What devices does Dental Direkt GmbH make?
Its most frequent FDA product codes are EIH (Powder, Porcelain, 5); NHA (Abutment, Implant, Dental, Endosseous, 2); EBG (Crown And Bridge, Temporary, Resin, 1).
Has Dental Direkt GmbH had device recalls?
openFDA lists no recalls under a recalling firm name matching Dental Direkt GmbH. Related entities may recall under other names.
Next steps
- See all 9 Dental Direkt GmbH clearances with predicates and recalls
- Run predicate analysis for product code EIH, Dental Direkt GmbH'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.