Manufacturer registered with FDA
Vertex-Dental B.V.
Soesterberg, Netherlands. Lists 11 dental device types with FDA across 1 registered establishment, and holds 7 510(k) clearances as applicant.
- Device types listed
- 11
- Brands and models
- 46
- 510(k) clearances
- 72010–2024
- Markets registered in
- 13208 registrations outside the US
- Establishments
- 1Netherlands
510(k) clearances per year, 2007–2026
Registered in 13 markets
Where regulators' registries name Vertex-Dental B.V. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Vertex-Dental B.V. | 7 clearances | 2010–2024 | Below |
| Canada | Health Canada | Registration holder | VERTEX-DENTAL B.V. | 56 | 2008–2021 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Vertex-Dental B.V.Vertex Dental B.V. · VERTEX-DENTAL B.V. | 31 | 2002–2018 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Vertex-Dental B.V. | 26 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | VERTEX-DENTAL B.V. | 25 | 2005–2024 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Vertex-Dental B.V.Vertex Dental B.V. | 24 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Vertex-Dental B.V. | 12 | 2022–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | Vertex Dental BV | 10 | 2012–2023 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | VERTEX-DENTAL BV | 9 | 2021–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Vertex-Dental B.V. | 7 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Vertex - Dental B.V.Vertex – Dental B.V. | 4 | — | Pure Global AI |
| China | NMPA | Registration holder | 沃特斯牙科有限公司Vertex-Dental B.V. | 2 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | VERTEX-DENTAL B.V. | 2 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Vertex-Dental B.V. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | CastapressCastavariaCeramill Denture 3D+Hot Curing 20 Min Type CNextDent BaseNextDent DentureNextDent Denture 3D+NextDent Jet BaseNextDent Jet TeethRapid Simplified 2 moreSelf-CuringThermodent (Confidential) | 2011 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | NextDent Jet BaseNextDent Jet TeethSaremco Print Crowntec | 2022 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | NextDent Jet BaseNextDent Jet TeethSaremco Print Crowntec | 2022 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | Ceramill Ortho FlexCeramill Ortho RigidDental LT ClearE-GuardNextDent Ortho ClearNextDent Ortho FlexNextDent Ortho Rigid | 2016 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | Saremco Print Crowntec | 2022 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Ceramill Ortho IBTCeramill TrayE-IDBNextDent Ortho IBTNextDent TrayVertex Trayplast | 2015 |
| Shellac Base PlateEEA · Class 1 | — | Maker | Ceramill Try-InNextDent Try-In | 2018 |
| Posterior with Metal Insert Artificial TeethELJ · Class 1 | — | Maker | Ceramill C&B MFHE-Dent 400NextDent C&BNextDent C&B MFH | 2016 |
| Backing and Facing Artificial TeethELK · Class 1 | — | Maker | Ceramill C&B MFHNextDent C&BNextDent C&B MFH | 2016 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | NextDent Ortho Flex | 2022 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Ceramill SGDental SGE-Guide TintNextDent SG | 2016 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Vertex-Dental B.V. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 4 Sep 2024 | K241071 | NextDent Jet Denture Base; NextDent Jet Denture Teeth | EBI Rebasing Repairing Relining Denture Resin |
| 20 Oct 2023 | K231388 | NextDent Base | EBI Rebasing Repairing Relining Denture Resin |
| 1 Nov 2019 | K191497 | NextDent Denture 3D+ | EBI Rebasing Repairing Relining Denture Resin |
| 30 Jun 2017 | K162572 | NextDent Denture, E-Denture | EBI Rebasing Repairing Relining Denture Resin |
| 1 Mar 2013 | K123220 | VERTEX THERMOSENS RIGID | EBI Rebasing Repairing Relining Denture Resin |
| 25 Mar 2011 | K102640 | VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS | EBI Rebasing Repairing Relining Denture Resin |
| 3 Dec 2010 | K102654 | VERTEX RAPID SIMPLIFIED | EBI Rebasing Repairing Relining Denture Resin |
Some of these clearances are listed with FDA today by another company: Proto3000 Inc. (3), Amann Girrbach AG (1), Imagine Milling Technologies, LLC (1).
Also lists devices cleared under other names
Vertex-Dental B.V. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Saremco Dental AG (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 21 Jan 2022 | K213343 | Saremco Print CROWNTEC | Saremco Dental AG | EBF Resin Tooth Shade Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| VERTEX-DENTAL B.V.FDA reg. 8030452 | Soesterberg Utrecht, Netherlands | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8030452). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.