Cavex Holland BV: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Cavex Holland BV” (first 1998, latest 2015), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 52 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 | 1 | 220 |
| 2015 | 1 | 142 |
| 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 |
|---|---|---|---|
| ELW | Material, Impression | 16 | 16 |
| EBF | Material, Tooth Shade, Resin | 6 | 6 |
| KLE | Agent, Tooth Bonding, Resin | 2 | 2 |
| EMA | Cement, Dental | 1 | 1 |
| EMB | Zinc Oxide Eugenol | 1 | 1 |
Review panels
- Dental (26)
Most recent Cavex Holland BV 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151535 | Cavex Cream Alginate | ELW | 2015-10-28 | 142 |
| K141092 | MARK3 | ELW | 2014-12-04 | 220 |
| K073539 | PROVISA CEM | EMB | 2008-01-31 | 45 |
| K072245 | EMULATE ADVANCED | ELW | 2007-11-08 | 87 |
| K062400 | IMPRESSIX, COLORCHANGE ALGINATE | ELW | 2006-11-16 | 92 |
| K061267 | SIMULATE, COLOR CHANGE ALGINATE | ELW | 2006-07-10 | 66 |
| K052455 | IMPRESSIX | ELW | 2005-11-23 | 77 |
| K051207 | CAVEX ORTHOTRACE | ELW | 2005-06-21 | 41 |
| K042806 | QUADRANT UNIT-1-BOND | KLE | 2004-11-24 | 43 |
| K032116 | TULIP COLORSWITCH | ELW | 2003-09-30 | 83 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cavex Holland BV.
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 Cavex Holland BV?
FDA lists 26 510(k) clearances under the applicant name “Cavex Holland BV” (first 1998, latest 2015), 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 Cavex Holland BV?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cavex Holland BV is 52 days.
Which FDA product codes appear under Cavex Holland BV?
The most frequent FDA product codes under this applicant name are ELW (Material, Impression, 16); EBF (Material, Tooth Shade, Resin, 6); KLE (Agent, Tooth Bonding, Resin, 2).
Next steps
- See all 26 Cavex Holland BV clearances with predicates and recalls
- Run predicate analysis for product code ELW, Cavex Holland BV'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.