Data / Medical devices / Netherlands / Vertex-Dental B.V.
Vertex-Dental B.V.: FDA-registered device maker in Soesterberg Utrecht, Netherlands, 9 510(k) clearances
Vertex-Dental B.V. is registered with the FDA (registration 8030452) in Soesterberg Utrecht, Netherlands. It lists 12 device types. The FDA files 9 510(k) clearances under its listings, the newest dated September 4, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8030452
- FEI number
- 3003943714
- Address
- Centurionbaan 190, Soesterberg Utrecht, Netherlands, 3769 AV
- Owner or operator
- Vertex-Dental B.V. (8030452)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- May 11, 2011
- Registered through
- 2027
- Brand names listed
- Castapress, Castavaria, Ceramill C&B MFH, Ceramill Denture 3D+, Ceramill Ortho Flex, Ceramill Ortho IBT, Ceramill Ortho Rigid, Ceramill SG and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Maintainer, Space Preformed, Orthodontic | DYT | 1 | Manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Exporter to the US | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Manufacturer | accessdata.fda.gov |
| Plate, Base, Shellac | EEA | 1 | Manufacturer | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
| Teeth, Artificial, Backing And Facing | ELK | 1 | Manufacturer | accessdata.fda.gov |
| Teeth, Artificial, Posterior With Metal Insert | ELJ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 4, 2024 | K241071 | NextDent Jet Denture Base; NextDent Jet Denture Teeth | EBI | Substantially Equivalent | Vertex-Dental B.V. | accessdata.fda.gov |
| October 20, 2023 | K231388 | NextDent Base | EBI | Substantially Equivalent | Vertex-Dental B.V. | accessdata.fda.gov |
| October 21, 2022 | K221022 | NextDent Ortho Flex | MQC | Substantially Equivalent | Vertex-Dental B.V. | accessdata.fda.gov |
| January 21, 2022 | K213343 | Saremco Print CROWNTEC | EBF | Substantially Equivalent | Saremco Dental AG | accessdata.fda.gov |
| November 1, 2019 | K191497 | NextDent Denture 3D+ | EBI | Substantially Equivalent | Vertex-Dental B.V. | accessdata.fda.gov |
| June 30, 2017 | K162572 | NextDent Denture, E-Denture | EBI | Substantially Equivalent | Vertex-Dental B.V. | accessdata.fda.gov |
| March 1, 2013 | K123220 | VERTEX THERMOSENS RIGID | EBI | Substantially Equivalent | Vertex-Dental B.V. | accessdata.fda.gov |
| March 25, 2011 | K102640 | VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS | EBI | Substantially Equivalent | Vertex-Dental B.V. | accessdata.fda.gov |
| December 3, 2010 | K102654 | VERTEX RAPID SIMPLIFIED | EBI | Substantially Equivalent | Vertex-Dental B.V. | accessdata.fda.gov |
Compare with other makers
- All makers of Plate, Base, Shellac
- All makers of Teeth, Artificial, Posterior With Metal Insert
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Teeth, Artificial, Backing And Facing
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Crown And Bridge, Temporary, Resin
Updated September 4, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.