(149 days)
NextDent Denture 3D+ is a light-cured resin indicated for the fabrication of denture bases fabricated in dental laboratories, including full and partial removable dentures. The material is an alternative to traditional heat cured and auto polymerization resins. NextDent Denture 3D+ is intended exclusively for professional dental work. Fabrication of denture bases with NextDent Denture 3D+ requires a computer-aided and manufacturing (CAD/CAM) system that includes the following scanner, design software, additive printer and post-cure unit:
Light-Cure Resin, provided in a container. NextDent Denture 3D+ dimethacrylic system, polymerized via photo initiators in a 3D printer setting. The color of the denture is determined by the addition of pigments. NextDent™ Denture 3D+ must be used in combination with the NextDent™ 5100 Figure4® 3D printer. Printer and resin must be optimized to each other in order to get complete and precise printed parts. If printer and resin are not optimized to each other this may have an adverse effect on the accuracy and physical quality of printed parts. The NextDent™ 5100 Figure4® 3D printer and the post-curing lightbox NextDent™ LC-PrintBox make use of a light source to polymerize the NextDent resin.
The provided text describes the acceptance criteria and the study results for the NextDent Denture 3D+ device, which is a light-cured resin for fabricating denture bases.
Here's an breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The device was tested for conformity with ISO 20795-1:2013 Dentistry – Base polymers - Part 1: Denture base polymers.
The acceptance criteria are the requirements defined in this standard for Type 4 materials.
| Acceptance Criteria (from ISO 20795-1:2013 for Type 4 Materials) | Reported Device Performance (NextDent Denture 3D+) |
|---|---|
| Mechanical properties (e.g., Ultimate Flexural strength, Flexural modulus, Water sorption, Water solubility, Residual monomer) | Compliant to requirements defined in ISO 20795-1 for Type 4 materials. |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation/intracutaneous reactivity, Subacute/subchronic systemic toxicity, Genotoxicity) | Compliant to requirements defined in ISO 10993-1/C1:2010, including parts 3, 5, 10, and 11, for permanent medical devices. |
| Re-use of print resin material | Can be used safely without impacting biological safety. |
| Residual monomers on 3D printed parts before post-curing | No monomers remain on the surface due to cleaning steps. |
| Printability and accuracy (horizontal and vertical orientation, build location, resin re-use) | Can be repeatedly and successfully printed with 80% accuracy of 100 µm; worst-case average product density of 6.39 g/mm, at 18-28°C. |
| Shelf-life | 2 years. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each test performed (e.g., number of test specimens for flexural strength, number of samples for biocompatibility).
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, the submitter is Vertex-Dental B.V. from The Netherlands, suggesting the testing was likely conducted in Europe or by contractors for a European company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable (N/A) as the device is a material (resin) and not an AI/software device that requires expert judgment for ground truth establishment. The ground truth here refers to the compliance with established physical, chemical, and biological standards.
4. Adjudication method for the test set
This information is N/A for the same reasons as above. The evaluation of material properties against ISO standards does not typically involve human adjudication in the way an AI diagnostic tool would.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is N/A. The device is a material (resin) for 3D printing dentures, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is N/A. The device is a material, not an algorithm.
7. The type of ground truth used
The ground truth used for this device is based on established industry standards and regulatory requirements:
- Physical and Chemical Properties: ISO 20795-1:2013 Dentistry – Base polymers - Part 1: Denture base polymers.
- Biocompatibility: ISO 7405:2008/A1:2013 and ISO 10993-1:2009/C1:2010 (including parts 3, 5, 10, and 11).
8. The sample size for the training set
This information is N/A. The device is a material, not a machine learning model, so there is no "training set" in the context of AI.
9. How the ground truth for the training set was established
This information is N/A. As stated above, there is no training set for this type of device.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.