(288 days)
NextDent™ Denture / E-Denture is a light-cured resin indication 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 is intended exclusively for professional dental work. Fabrication of denture bases with NextDent ™ Denture / E-Denture requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer and post-cure unt.
NextDent™ Denture / E-Denture 3D-printing material is a light-cured resin indicated for the manufacturing of denture bases. The material is used in a 3D printer, which prints the shape determined by a 3D stereolithographic drawing. After printing, the printed product is placed in a UV-light curing box for final polymerization.
This document describes the premarket notification (510(k)) for the NextDent™ Denture/E-Denture, a light-cured resin for manufacturing denture bases. The focus of the provided text is on demonstrating substantial equivalence to a predicate device, primarily through bench testing and biocompatibility assessments, rather than an AI/ML-driven diagnostic or assistive device study.
Therefore, many of the requested criteria (e.g., sample size for test set, number of experts for ground truth, MRMC study, effect size of human reader improvement with AI, standalone algorithm performance, training set details) are not applicable to this type of medical device submission.
However, I can extract the relevant acceptance criteria and performance data related to the physical properties and biocompatibility of the material.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally defined by the relevant ISO standards, specifically ISO 20975-1 for "Dentistry - Base polymers - Part 1: Denture base polymers" for mechanical properties, and ISO 10993-1 for biocompatibility.
| Acceptance Criteria (Standard / Test) | Reported Device Performance (Result for NextDent™ Denture/E-Denture) |
|---|---|
| Mechanical Properties (ISO 20975-1) | Complies with requirements for Type 4 materials, except for water solubility. |
| Flexural strength | Tested and meets requirements. |
| Flexural modulus | Tested and meets requirements. |
| Water sorption | Tested and meets requirements. |
| Water solubility | Slightly exceeds requirement for Type 4 materials, but meets criteria for Type 2 materials. |
| Residual monomer | Tested and meets requirements. |
| Biocompatibility (ISO 10993-1) | All aspects addressed, device considered safe. |
| Cytotoxicity (ISO 10993-5) | Tested and meets requirements. |
| Sensitization (ISO 10993-10) | Tested and meets requirements. |
| Irritation or intracutaneous reactivity (ISO 10993-10) | Tested and meets requirements. |
| Subacute/subchronic systemic toxicity (ISO 10993-3) | Tested and meets requirements. |
| Genotoxicity (ISO 10993-3) | Tested and meets requirements. |
| Carcinogenicity Risk Assessment | Considered and addressed. |
| Reproductive/developmental/organ toxicity Risk Assessment | Considered and addressed. |
| Immunotoxicity Risk Assessment | Considered and addressed. |
| Presence of phthalates Risk Assessment | Considered and addressed. |
| Shelf-Life | 2 years |
| Compatibility with CAD/CAM Systems | Compatible with specific listed scanners, design software, printers, and post-cure units. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The exact sample sizes for each specific mechanical and biocompatibility test are not provided in this summary document. The document states that tests were "conducted on NextDent™ Denture / E-Denture using all the compatible CAD/CAM systems."
- Data Provenance: Not specified, but generally, such tests would be conducted in a controlled laboratory setting (likely within the manufacturer's R&D or QA facilities or by a certified testing lab). The summary does not indicate country of origin for actual data collection, or if it's retrospective or prospective, as these terms are usually more relevant for clinical studies than material verification testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This submission is for a material (resin) used in manufacturing, not an AI-driven diagnostic device requiring expert interpretation of medical images or data. Ground truth here is established by standardized physical/chemical and biological testing methods, not expert consensus.
4. Adjudication method for the test set
- Not applicable. See point 3. Testing results are quantitative/qualitative measurements against established standards, not subject to human adjudication in the context of diagnostic interpretation.
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
- Not applicable. This device is a material, not an AI or imaging device involving human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a material, not an algorithm.
7. The type of ground truth used
- The "ground truth" for this device's performance is established by validated laboratory testing methods and industry standards (ISO standards) for physical/mechanical properties and biocompatibility.
- For mechanical properties: Quantitative measurements (e.g., flexural strength, water solubility) compared against specified limits in ISO 20975-1.
- For biocompatibility: Biological assays (e.g., cytotoxicity, genotoxicity) performed according to ISO 10993 series and evaluated against pass/fail criteria.
8. The sample size for the training set
- Not applicable. This is a material, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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.