Vertex-Dental B.V.
NL-MF-000019230 · Netherlands · Soesterberg
Vertex-Dental B.V. is registered in the European database on medical devices as a manufacturer, with 50 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 50 |
|---|
Most frequent device types declared: Denture Base, Photo-curing resin, Indirect Bonding Tray Resins, Photo-Cured, NDCMBL01000_01, NDCMN301000_01, NDD3TP01000_01.
Among these devices, 2 are declared implantable.
Devices declared under this manufacturer
- Ceramill SG
- Ceramill Tray
- E - Guide Tint
- E-IDB
- NextDenbt Tray
- NextDent
- NextDent Base
- NextDent Jet Base
- NextDent Jet Teeth
- NextDent Ortho IBT
- NextDent SG
- NextDent Tray
Showing 12 of 50 declared devices.
Catalogue references include NDD3TP01000_01, NDJTBSLP01000, NDOICL01000_2, NDSGOR01000_2, NDTRBL01000_2, NDTRPI01000_5.
European nomenclature codes declared: Q0102050199, Q010699.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | VERTEX-DENTAL B.V. (NL) · FDA 8030452 |
| Devices in EUDAMED | 50 |
| Country of registration | Netherlands |
Device-level evidence
| Devices with a numeric GTIN | 50 |
|---|---|
| Found in the U.S. device database | 44 |
| Share | 88.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | VERTEX-DENTAL B.V. |
North American profile: Both markets. Vertex-Dental B.V. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
BE24/00000143 | supplemented | 2029-06-03 |