(106 days)
E-Denture Pro is a light-curable resin indicated for the fabrication of denture bases fabricated in dental laboratories for full removable dentures. The material is an alternative to traditional heat-curable and auto polymerizing resins. E-Denture Pro is intended exclusively for professional dental work. Fabrication of denture bases with E-Denture Pro requires a computer-aided and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on a digital impression, a digital light processing (DLP) printer, and curing light equipment.
The E-Denture Pro system combines a scanner with design software, the light-curable resin, a 3D printer and a curing unit. These components are used together during the manufacture of the customized denture base for the removable full denture. The light-curable resin is a proprietary composition of acrylates, methacrylates, methacrylated oligomers and monomers, photo initiators, colorants/dyes and absorbers. It is used by dental laboratories and dental practices to make the denture bases for removable full dentures. The resin is offered in lightproof 1 kg PE bottles along with a programmed chip (referred to as TAG), which is required for use with the 3D printer. The TAG contains information identifying the resin material, name and amount. E-Denture Pro resin is an alternative material to heat-curable and auto-polymerizable resins. EnvisionTECs Perfactory® 3D-Printer models designed and validated for use with the E-Denture Pro light cured resin are: EnvisionOne cDLM, with LED Vida Series, with LED P4K Series, with LED D4K Series, with LED
The document is a 510(k) Summary for the EnvisionTEC E-Denture Pro, a light-curable resin for fabricating denture bases. The study outlined is a bench testing study comparing the E-Denture Pro to a predicate device and relevant standards, not a clinical study involving human patients or complex AI algorithms. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not applicable to this type of device and study.
Here's the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the requirements of DIN EN ISO 20795-1:2013, Dentistry – Base Polymers and ISO 10993 for biocompatibility. The reported device performance is compared with the predicate device (K191497, NextDent Denture 3D+).
| Acceptance Criteria (Standard / Predicate Device) | Reported Device Performance (E-Denture Pro) | Outcome |
|---|---|---|
| Material Properties (DIN EN ISO 20795-1:2013) | (Tested and met requirements) | Met |
| - Surface quality | (Met requirements) | Met |
| - Dimensional stability | (Met requirements) | Met |
| - Color and color stability | (Met requirements) | Met |
| - Translucency | (Met requirements) | Met |
| - Freedom from porosity | (Met requirements) | Met |
| - Bonding to synthetic teeth | (Met requirements) | Met |
| - Residual monomer | (Met requirements) | Met |
| - Sorption | (Met requirements) | Met |
| - Solubility | (Met requirements) | Met |
| Biocompatibility (ISO 10993) | (Biocompatible, non-toxic) | Met |
| - Cytotoxicity Study (Part 5) | (Met requirements) | Met |
| - Guinea Pig Maximization Sensitization Test (Part 10) | (Met requirements) | Met |
| - Intracutaneous Injection in Rabbits (Part 10) | (Met requirements) | Met |
| - Acute Systemic Toxicity in Mice (Part 11) | (Met requirements) | Met |
| Flexural Strength (Predicate: 81.2 MPa) | 72.7 MPa | Similar |
| Secant Modulus (Predicate: 3113 MPa) | 2192 MPa | Similar |
| Flexural Strain (Predicate: 2.8 % at break) | >5.0 % at break | Similar |
Note: The document states that the testing "produced results that are similar to the predicate" and that "the noted differences... raise no new questions of safety and effectiveness." This implies the performance values for Flexural Strength, Secant Modulus, and Flexural Strain, while not identical, are considered acceptable by the FDA for substantial equivalence.
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact sample sizes (number of specimens or denture bases) used for each physical and chemical test.
- Data Provenance: The data is from laboratory testing conducted by EnvisionTEC, likely in Germany (based on the submitter's address). This is considered prospective data generation for the purpose of regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a materials science and engineering characterization study, not an expert-based diagnostic or classification study. The "ground truth" is established by the specified international standards (DIN EN ISO 20795-1:2013 and ISO 10993).
4. Adjudication method for the test set
Not applicable. The tests are quantifiable material property measurements against established standards, not subject to expert adjudication.
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 is not an AI-assisted diagnostic device, nor a study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a material (resin) used in a CAD/CAM system, not a standalone algorithm.
7. The type of ground truth used
The ground truth used for performance evaluation is based on:
- International Standards: DIN EN ISO 20795-1:2013 (Dentistry – Base Polymers) for mechanical and physical properties of denture bases.
- International Biocompatibility Standards: ISO 10993 for biological evaluation of medical devices.
- Comparison to a Legally Marketed Predicate Device: The performance is also benchmarked against the NextDent Denture 3D+ (K191497) to demonstrate substantial equivalence.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable (as there is no training set).
§ 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.