Vertex-Dental B.V.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Vertex-Dental B.V.” (first 2010, latest 2024), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 155 days. Since 2017 the median was 161 days, against 142 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 | 1 | 137 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 288 |
| 2018 | 0 | — |
| 2019 | 1 | 149 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 198 |
| 2023 | 1 | 161 |
| 2024 | 1 | 138 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Vertex-Dental B.V. took a median 161 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 142 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 7 | 7 |
| MQC | Mouthguard, Prescription | 1 | 1 |
Review panels
- Dental (8)
Most recent Vertex-Dental B.V. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241071 | NextDent Jet Denture Base; NextDent Jet Denture Teeth | EBI | 2024-09-04 | 138 |
| K231388 | NextDent Base | EBI | 2023-10-20 | 161 |
| K221022 | NextDent Ortho Flex | MQC | 2022-10-21 | 198 |
| K191497 | NextDent Denture 3D+ | EBI | 2019-11-01 | 149 |
| K162572 | NextDent Denture, E-Denture | EBI | 2017-06-30 | 288 |
| K123220 | VERTEX THERMOSENS RIGID | EBI | 2013-03-01 | 137 |
| K102640 | VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS | EBI | 2011-03-25 | 192 |
| K102654 | VERTEX RAPID SIMPLIFIED | EBI | 2010-12-03 | 80 |
Recalls
openFDA lists no recalls under a recalling firm named Vertex-Dental B.V..
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 Vertex-Dental B.V.?
FDA lists 8 510(k) clearances under the applicant name “Vertex-Dental B.V.” (first 2010, latest 2024), across 2 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 Vertex-Dental B.V.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vertex-Dental B.V. is 155 days. Since 2017: 161 days, versus 142 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Vertex-Dental B.V.?
The most frequent FDA product codes under this applicant name are EBI (Resin, Denture, Relining, Repairing, Rebasing, 7); MQC (Mouthguard, Prescription, 1).
Next steps
- See all 8 Vertex-Dental B.V. clearances with predicates and recalls
- Run predicate analysis for product code EBI, Vertex-Dental B.V.'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.