Instructions for Use

1. Device identification

DentVIS — standalone dental CAD software, Class I medical device pursuant to Regulation (EU) 2017/745 (MDR), Rule 11. CE marked. UDI-DI: 08594236870008, Basic UDI-DI: 859423687DentVISY4.

Manufacturer: Dentmall s.r.o., Pivovarská 214/4, 370 01 České Budějovice, Czech Republic. SRN: CZ-MF-000053272. Full regulatory information is available on the regulatory information page.

2. Intended purpose

CAD software for preparation of digital dental models for orthodontic and prosthetic appliance manufacturing. Not for diagnostic use. For professional use only.

The software does not provide diagnostic or therapeutic recommendations. Clinical decisions are made exclusively by a qualified healthcare professional.

3. Intended users

Qualified dental professionals (dentists, orthodontists, dental technicians) trained in digital dental workflows. The software is not intended for use by laypersons.

Typical environment of use: dental practices, dental laboratories and educational institutions.

4. System requirements

DentVIS is available as a native application for macOS, Windows and iPadOS. Minimum requirements: Windows — Windows 10/11, 8 GB RAM, GPU with OpenGL 3.3+ support; macOS — macOS 12 (Monterey) or later, 8 GB RAM; iPadOS — iPadOS 16 or later, iPad with an M1 chip or newer. Recommended: 16 GB RAM, dedicated graphics and a display with a resolution of 1920×1080 or higher.

Supported input formats for 3D dental scans: STL, OBJ, PLY. Export formats: STL (3D printing / milling), VIS (native case format) and CSV (trimline data). An internet connection is required for account sign-in, licensing and optional cloud synchronization; model editing itself runs locally on the device.

5. Basic operation

A typical case is prepared in the following steps:

1. Create a case and import scans — create a new case and import the upper and/or lower jaw scan from a file. The jaw assignment (upper / lower) is set by you at import. Identify the case with a neutral case label; do not enter data identifying the person to whom the model belongs.
2. Orient the model — align the occlusal plane in the guided orientation step.
3. Trim — remove unneeded parts of the scan.
4. Segment teeth — run tooth segmentation and review or adjust the resulting tooth boundaries.
5. Prepare the Virtual Setup — reposition individual teeth on the timeline to prepare the setup model.
6. Export — export the resulting models in STL format as a basis for appliance manufacturing.

6. Warnings and precautions

• The software must not be used as the sole basis for clinical decision-making. Outputs of the software must always be verified by a qualified professional before any clinical use.
• Software outputs are not directly usable as a medical device. Exported models are a basis for appliance manufacturing; review and verify the design before production.
• Verify the jaw assignment. The software does not detect automatically which scan is the upper and which is the lower jaw. Verify the assignment at import; a swapped assignment becomes apparent only later in the workflow.
• Verify model integrity after import. Imported meshes are automatically optimized and repaired (mesh simplification, removal of defects, closing of small holes). Visually verify that the model faithfully represents the scanned situation before continuing.
• Measurement values are for reference only. They are not clinically calibrated. Do not base clinical decisions on measurements displayed by the software; use calibrated measuring instruments for clinical purposes.
• The user is responsible for the correct interpretation and use of the visualized data.
• Keep the software up to date. Cases saved with a newer version of the software cannot be opened by older versions. When collaborating across multiple devices, use the same software version on all of them.
• Not for diagnostic use. The software must not be used to establish a diagnosis.

Contraindications: not applicable — the software is a CAD tool for the visualization and editing of 3D data and has no direct therapeutic or diagnostic effect.

7. Case data and synchronization

Case data is stored locally on your device; the device is the primary storage of your data. When cloud synchronization is enabled, case data is synchronized through the manufacturer's cloud service to your other devices signed in to the same account. The synchronization status of each case is indicated in the case list. Cloud synchronization is not a backup service — back up your data regularly. Details on data processing are provided in the Privacy Policy.

8. Incident reporting

Any serious incident that has occurred in relation to the device must be reported to the manufacturer at dentmall@email.cz and to the competent authority of the EU Member State in which the user is established. In the Czech Republic this is SÚKL (State Institute for Drug Control, www.sukl.cz), to which users are required to report serious incidents pursuant to Act No. 375/2022 Coll., on medical devices; users in other Member States report in accordance with their national law. The manufacturer reports serious incidents to the competent authorities in accordance with Article 87 of Regulation (EU) 2017/745.

9. Electronic instructions for use

These Instructions for Use are provided in electronic form and are an integral part of the device. A printed copy can be requested from the manufacturer free of charge at dentmall@email.cz and will be provided within 7 calendar days.

10. Contact

Dentmall s.r.o., Pivovarská 214/4, 370 01 České Budějovice, Czech Republic
E-mail: dentmall@email.cz · Web: https://www.dentvis.com