Navident EVO Cart
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- Navident EVO cart EUDAMED
- Device Name
- Navident EUDAMED
- Model / Reference
- 955-ND-ND EUDAMED955-ND-ND-201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07540209956478 EUDAMED
- Basic UDI-DI
- 7540209955-ND-NDUL EUDAMED
- EMDN Code
- Z12011401 SURGICAL NAVIGATION SYSTEM EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Navident EVO Cart is a Computer-Assisted Surgery Device (Nomenclature Code: Z12011401) designed for real-time surgical navigation in dental procedures. It provides visual guidance akin to a GPS system, enabling precise alignment and execution of hard-tissue interventions such as implants or bone grafts. By enhancing spatial accuracy, it supports clinicians in reducing procedural risks and improving clinical outcomes.
The device is supplied as a reusable, non-sterile system (Reference: 955-ND-ND-201) and is intended for use in dental operating environments. It is not implantable, latex-free, or intended for medicinal administration. The Navident EVO Cart carries FDA 510(k) clearance and EU MDR compliance, with a UDI (07540209956478) for traceability. Storage and handling follow standard medical device protocols, as outlined in its regulatory documentation.
Frequently asked questions
What types of dental procedures can the Navident EVO Cart assist with, and how does it improve accuracy during surgery?
The Navident EVO Cart is designed for real-time surgical navigation in dental procedures, specifically for hard-tissue interventions like dental implants or bone grafts. It functions like a GPS system, providing visual guidance to enhance spatial accuracy. By doing so, it helps clinicians align and execute procedures with greater precision, reducing risks and improving clinical outcomes.
Is the Navident EVO Cart reusable, and if so, what are the recommended storage and handling guidelines?
Yes, the Navident EVO Cart is supplied as a reusable system. Since it is non-sterile, it must be handled according to standard medical device protocols outlined in its regulatory documentation. Proper storage and reprocessing are critical to maintain its functionality and ensure patient safety.
What regulatory approvals does the Navident EVO Cart hold, and how does this affect its traceability?
The Navident EVO Cart holds FDA 510(k) clearance and EU MDR compliance, confirming its regulatory standing in both markets. It includes a Unique Device Identifier (UDI) with the code 07540209956478, enabling full traceability for inventory, recall, and compliance tracking as required by regulatory bodies.
Does the Navident EVO Cart come in multiple sizes or models, and if so, how are they differentiated?
The device is listed under the model reference 955-ND-ND-201 and does not specify multiple sizes or models in the provided data. It is supplied as a single system (Navident EVO Cart) designed for general dental navigation applications, ensuring compatibility with various hard-tissue procedures.
Is the Navident EVO Cart intended for use with medicinal products, or is it purely a standalone surgical navigation tool?
No, the Navident EVO Cart is not intended for medicinal administration or use with medicinal products. It is a standalone Computer-Assisted Surgery Device (Nomenclature Code: Z12011401) designed exclusively for real-time surgical guidance in dental procedures, ensuring it remains a non-medicinal tool.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Navident EVO - ClaroNav, ClaroNav, Navident EVO by Claronav - CADCAM Solutions - WTI Dental
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233563 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K161406 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K210947 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K163439 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 7540209955-ND-NDUL | Class IIa | Active |
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Manufacturer
- Manufacturer
- ClaroNav Inc.
- EUDAMED SRN
- CA-MF-000028837
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED f9bdfb1d-5dac-4ff6-8c33-58797f768ed3 61 fields · synced Sep 30, 2026
- FDA 510(k) K233563 1 fields · synced May 18, 2026