(151 days)
Foundation Dental Resin is used to fabricate teeth and gums that are intended for use as removable full and partial dentures as well as occlusal splints and night guards. This dental resin material is used by dental professionals including dentists and dental technicians. They can be used to make various sizes, shapes, and color shades for anterior and posterior preformed plastic teeth. We are applying an approval as dental resin material as well as preformed product using this material.
Foundation Dental Resin is intended for use by a qualified/trained dentists or dental laboratory technicians on dental plates for dentures (false teeth), temporary crowns, artificial teeth and orthodontic devices.
Foundation Dental Resin material is a thermoplastic resin that is used to fabricate dental prosthesis. The resin is used in an injection molding or pressing device to fabricate the prostheses. Foundation Dental Resin, which is characterized by the fact that the principal component is a copolymer polypropylene.
This is a 510(k) summary for a dental resin material, Foundation Dental Resin, seeking approval from the FDA. The document focuses on demonstrating substantial equivalence to a predicate device (Cosmetic Dental Materials, Inc.'s DuraFlex (K063626)) rather than presenting a study for meeting specific acceptance criteria for a novel device. Therefore, much of the requested information about device performance against acceptance criteria, sample sizes, expert involvement, and ground truth establishment, which are typical for studies proving novel device efficacy, is not present in this type of submission.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a table of specific quantitative acceptance criteria with corresponding performance data. Instead, it states that "Extensive testing has been performed on the Foundation Dental Resin to demonstrate compliance with the following EN ISO standards" and mentions biocompatibility tests. The general statement is that the product is "as safe and effective as the predicate device."
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Biocompatibility | Compliance with EN ISO standards for genotoxicity, irritation, toxicity, and cytotoxicity. | Stated to be safe for intended use; animal testing results are attached (but not included in the provided text). |
| Material Characteristics | Similar to predicate device. Principal component is copolymer polypropylene. No bisphenol A (BPA); does not elude BPA. No reported allergic reactions (anecdotal study). | Highlights differences from acrylic resins (no PMMA, no residual monomer issues). |
| Physical Properties | Similar to predicate device. | "Extensive testing has been performed... for intended use." Performance Data Document is attached (but not included in the provided text). |
| Handling Characteristics | Similar to predicate device. | No specific data provided within the text. |
| Intended Use & Functionality | Similar to predicate device. | Used to fabricate removable full and partial dentures, occlusal splints, and night guards. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document mentions "Extensive testing" and "animal testing results" but does not provide numbers for subjects or samples tested.
- Data Provenance: Not explicitly stated but implies laboratory testing for biocompatibility and physical properties. It does not mention clinical trials with human subjects. The anecdotal study regarding allergic reactions does not specify its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/Not mentioned. This information is typically relevant for studies involving diagnostic or prognostic devices where expert consensus defines ground truth. For a material science device like dental resin, ground truth is established through adherence to material standards and laboratory tests.
4. Adjudication method for the test set:
Not applicable/Not mentioned. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among experts when establishing ground truth, typically in image-based diagnostic studies. This is not relevant for the type of testing described for a dental resin material.
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 dental resin material, not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating the impact of AI on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. As stated above, this is a material science device, not an algorithm.
7. The type of ground truth used:
For the performance and safety testing, the "ground truth" is adherence to established EN ISO standards for biocompatibility and material properties. For the claim of "no allergic reactions," it relies on an "anecdotal study," which is weaker than controlled clinical data.
8. The sample size for the training set:
Not applicable/Not mentioned. Training sets are relevant for machine learning algorithms. This document describes a physical material, not an algorithm that requires training.
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.