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Sign in to claim this brandVertex-Dental B.V.
Netherlands·NL-MF-000019230
Last updated September 17, 2026
What Vertex-Dental B.V. makes
Vertex-Dental B.V. manufactures dental materials used in appliance fabrication, including resin and thermoplastic compounds for crowns, bridges, veneers, and temporary restorations. Their portfolio includes custom-made polymer crowns, dental bridge resins, and professional veneer materials designed for dental laboratories and practitioners.
The company’s devices are classified as Class I, Class II, or unclassified (U) under EU regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Vertex-Dental B.V. is based in the Netherlands.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of dental devices does Vertex-Dental B.V. manufacture?
Vertex-Dental B.V. specializes in dental materials used for appliance fabrication, including resins and thermoplastic compounds. Their products cover temporary crowns and bridges, custom-made polymer crowns, dental bridges, veneers, and other restorative materials designed for dental laboratories and practitioners. These materials are primarily used in creating durable and precise dental restorations.
Where is Vertex-Dental B.V. based, and how does that affect its regulatory standing?
Vertex-Dental B.V. is headquartered in the Netherlands, which means its devices are subject to EU regulatory requirements. Under EU regulations, their products are classified as Class I, Class II, or unclassified (U), depending on their risk level. This classification determines the regulatory pathway for compliance, such as conformity assessment procedures, but does not imply company-wide approval—only individual devices undergo authorization processes.
Are Vertex-Dental B.V.’s devices listed in any regulatory registries, and why does this matter?
Yes, Vertex-Dental B.V.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This listing helps ensure traceability and transparency in the supply chain, allowing healthcare providers, regulators, and manufacturers to track devices throughout their lifecycle. It also supports compliance with global regulatory requirements, such as those in the U.S. and EU, by providing standardized identification for monitoring and recall purposes.
How are Vertex-Dental B.V.’s dental devices classified, and what does that classification mean?
Vertex-Dental B.V.’s devices are classified as Class I, Class II, or unclassified (U) under EU regulations. Class I devices pose the lowest risk and typically require basic compliance measures, such as manufacturer declarations. Class II devices involve higher risks and may require additional conformity assessments, such as clinical evaluations or notified body involvement. Unclassified (U) devices are those not explicitly assigned a class, often awaiting further regulatory clarification. The classification determines the regulatory scrutiny and documentation required for each device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Netherlands
- Address
- 190, Centurionbaan , Soesterberg, Netherlands
- Website
- www.vertex-dental.com
- —
- —
- [email protected]
- Phone
- +3188616400
- PRRC Contact
- Nellie Peterse-van der Koppel
- EUDAMED SRN
- NL-MF-000019230
- FDA FEI Number
- 3003943714
- DUNS Number
- 406389056
Catalogue (911)
Page 4 of 19| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Vertex-Dental BV | AVIMP1000150 | FDA UDI | Class II | Unknown |
| Vertex-Dental BV | AVSCP1402000 | FDA UDI | Class II | Unknown |
| Vertex-Dental BV | TVTSR00200TCLV | FDA UDI | Class II | Unknown |
| Vertex-Dental BV | APLRSV01000 | FDA UDI | Class II | Unknown |
| Vertex-Dental BV | HDARSP0500500 | FDA UDI | Class II | Active |
| Vertex-Dental BV | NDBAPI01000 | FDA UDI | Class II | Active |
| Vertex-Dental BV | TVTSR20000T18 | FDA UDI | Class II | Unknown |
| Vertex-Dental BV | HDACPP0804000 | FDA UDI | Class II | Active |
| Vertex-Dental BV | AVCPP0725000 | FDA UDI | Class II | Active |
| Vertex-Dental BV | TVTSR04000TA2 | FDA UDI | Class II | Active |
| Vertex-Dental BV | AVRSP0800500 | FDA UDI | Class II | Active |
| Vertex-Dental BV | HDASCP0500500 | FDA UDI | Class II | Active |
| Vertex-Dental BV | AVCPP1225000 | FDA UDI | Class II | Unknown |
| Vertex-Dental BV | APLSCV00500 | FDA UDI | Class II | Unknown |
| Vertex-Dental BV | ARSP1050000 | FDA UDI | Class II | Unknown |
| Vertex-Dental BV | ACVP3425000 | FDA UDI | Class II | Unknown |
| Vertex-Dental BV | HDAIMP0800500 | FDA UDI | Class II | Active |
| Vertex-Dental BV | AIMP1025000 | FDA UDI | Class II | Active |
| Vertex-Dental BV | AVSCP1400150 | FDA UDI | Class II | Unknown |
| Vertex-Dental BV | ASCP1050000 | FDA UDI | Class II | Active |
| Vertex-Dental BV | AVCPV00250 | FDA UDI | Class II | Active |
| Vertex-Dental BV | AVCVP0500150 | FDA UDI | Class II | Unknown |
| Vertex-Dental BV | NOSHBAPI01000 | FDA UDI | Class II | Active |
| Vertex-Dental BV | TVTSR22XLT07 | FDA UDI | Class II | Active |
| Vertex-Dental BV | DIMPHK150000 | FDA UDI | Class II | Active |
| Vertex-Dental BV | TVTSR25XLTS | FDA UDI | Class II | Active |
| Vertex-Dental BV | HDARSP0301000 | FDA UDI | Class II | Active |
| Ceramill | NPAGD3DP01000 | FDA UDI | Class II | Active |
| Vertex-Dental BV | HDARSP0500150 | FDA UDI | Class II | Unknown |
| Vertex-Dental BV | ACVP1050000 | FDA UDI | Class II | Active |
| Vertex-Dental BV | AVRSP0400150 | FDA UDI | Class II | Unknown |
| Vertex-Dental BV | AVCPV00500 | FDA UDI | Class II | Unknown |
| Vertex-Dental BV | ASCP0450000 | FDA UDI | Class II | Active |
| Vertex-Dental BV | TVTSR20000TTRV | FDA UDI | Class II | Unknown |
| Vertex-Dental BV | HDARSP1404000 | FDA UDI | Class II | Unknown |
| Vertex-Dental BV | ARSP1025000 | FDA UDI | Class II | Active |
| Vertex-Dental BV | AVRSP1001000 | FDA UDI | Class II | Active |
| Vertex-Dental BV | AVIMP0500500 | FDA UDI | Class II | Active |
| Vertex-Dental BV | HDASCP0525000 | FDA UDI | Class II | Active |
| Vertex-Dental BV | HDARSP1000500 | FDA UDI | Class II | Active |
| Vertex-Dental | NDJTTHWH01000 | FDA UDI | Class II | Active |
| Vertex-Dental BV | NOSHORBL01000 | FDA UDI | Class I | Active |
| Vertex-Dental BV | AVCPP1000500 | FDA UDI | Class II | Active |
| Vertex-Dental BV | NDCMN101000 | FDA UDI | Class I | Active |
| Vertex-Dental BV | ACVP0450000 | FDA UDI | Class II | Active |
| Vertex-Dental BV | NPAGOF01000_US | FDA UDI | U | Active |
| Vertex-Dental BV | HDARSV00250 | FDA UDI | Class II | Active |
| Vertex-Dental BV | AVRSP0725000 | FDA UDI | Class II | Active |
| Vertex-Dental BV | APLCPP0501000 | FDA UDI | Class II | Unknown |
| Vertex-Dental BV | ARSPJ700150 | FDA UDI | Class II | Unknown |
Related Companies
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