Regulatory information
This page summarizes the regulatory status of the DentVIS software as a medical device in the European Union.
Intended purpose
DentVIS is standalone dental CAD software intended for the visualization and editing of 3D dental models and the preparation of orthodontic setup models. It provides tools for the visualization of 3D dental models, segmentation of individual teeth and preparation of virtual orthodontic setups.
DentVIS is intended to be used exclusively by qualified dental professionals. The software does not provide diagnostic or therapeutic recommendations. Clinical decisions are made exclusively by a qualified healthcare professional, and all outputs of the software are subject to review, verification and approval by a qualified professional.
Measurement values displayed by the software are for reference only.
Classification
DentVIS is classified as a Class I medical device in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (MDR).
EU Declaration of Conformity
Dentmall s.r.o. declares under its sole responsibility that the medical device DentVIS complies with the applicable requirements of Regulation (EU) 2017/745 on medical devices. The EU Declaration of Conformity has been drawn up in accordance with Article 19 and Annex IV of the MDR. The conformity assessment was carried out under the procedure applicable to Class I devices (Article 52(7) MDR); the involvement of a notified body is not required for this class of device. The device bears the CE marking of conformity.
A copy of the EU Declaration of Conformity is available from the manufacturer on request.
Registration
The manufacturer and the device are registered in the European database of medical devices (EUDAMED):
| Device (trade name) | DentVIS |
|---|---|
| Device model | DentVIS |
| Version / reference number | 3.0.1 |
| Risk class | Class I (MDR) |
| Device type | Standalone software (medical device software) |
| EMDN nomenclature code | Z12119092 |
| Basic UDI-DI | 859423687DentVISY4 |
| UDI-DI | 08594236870008 |
| Issuing entity | GS1 |
| Market status | On the EU market |
| Manufacturer | Dentmall s.r.o. |
| Person responsible for regulatory compliance | MDDr. Ondřej Masák |
| Manufacturer SRN (Actor ID) | CZ-MF-000053272 |
| Registered address | Pivovarská 214/4, 370 01 České Budějovice, Czech Republic |
Reporting of incidents
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and to the competent authority of the EU Member State in which the user and/or patient is established. In the Czech Republic, the competent authority is the State Institute for Drug Control (SÚKL).
Report incidents to the manufacturer at: dentmall@email.cz
Manufacturer contact
Dentmall s.r.o.
IČO: 09041036
Pivovarská 214/4, 370 01 České Budějovice, Czech Republic
Person responsible for regulatory compliance: MDDr. Ondřej Masák
dentmall@email.cz