Vertex-Dental B.V.
Soesterberg Utrecht, NL
VERTEX-DENTAL B.V. appears in FDA device records in Soesterberg Utrecht, NL. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Vertex-Dental B.V. between 2010 and 2024. The busiest year on record is 2010, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241071 | NextDent Jet Denture Base; NextDent Jet Denture Teeth | EBI | Substantially Equivalent | |
| K231388 | NextDent Base | EBI | Substantially Equivalent | |
| K221022 | NextDent Ortho Flex | MQC | Substantially Equivalent | |
| K191497 | NextDent Denture 3D+ | EBI | Substantially Equivalent | |
| K162572 | NextDent Denture, E-Denture | EBI | Substantially Equivalent | |
| K123220 | VERTEX THERMOSENS RIGID | EBI | Substantially Equivalent | |
| K102640 | VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS | EBI | Substantially Equivalent | |
| K102654 | VERTEX RAPID SIMPLIFIED | EBI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8030452 | 3003943714 | VERTEX-DENTAL B.V. | Centurionbaan 190, Soesterberg Utrecht 3769 AV NL | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NDPAccessories, Implant, Dental, Endosseous
- PZYAdditively Manufactured, Preformed, Resin Denture Tooth
- EBGCrown And Bridge, Temporary, Resin
- DYTMaintainer, Space Preformed, Orthodontic
- EBHMaterial, Impression Tray, Resin
- EBFMaterial, Tooth Shade, Resin
- MQCMouthguard, Prescription
- EEAPlate, Base, Shellac
- KMYPositioner, Tooth, Preformed
- EBIResin, Denture, Relining, Repairing, Rebasing
- ELKTeeth, Artificial, Backing And Facing
- ELJTeeth, Artificial, Posterior With Metal Insert
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain