(79 days)
(1) fillings in Class I, III, IV, V and small Class II cavities; (2) fillings in deciduous teeth; (3) eroded and abraded cervical areas (wedge-shaped defects); (4) fabricating indirect anterior laminate veneers and tooth colored inlays; and (5) repairing facings on crowns and bridges.
modified materials, referred to by the tradenames Pertac® II and Pertac® II Aplitip®, are intended as composite filling materials
This 510(k) summary (K962440) describes a modification to an already cleared tooth shade resin material (Pertac-Hybrid). The new materials, Pertac II and Pertac II Aplitip, are composite filling materials.
Based on the provided text, the acceptance criteria and study details are quite limited. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical trial data as would be expected for a novel, high-risk device. The information primarily addresses material properties and safety tests for a component.
Here's a breakdown of the requested information based only on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety of Peroxide Component (general) | Peroxide component confirmed safe (skin irritation, eye irritation, Ames, acute toxicity tests performed) |
| DIN and ISO standards for dental composite material | Pertac® II and Pertac® II Aplitip® meet the requirements. |
| Substantial Equivalence to Predicate Product (Pertac®-Hybrid®) | Physical and technical characteristics of Pertac® II/Pertac® II Aplitip® compared to Pertac®-Hybrid®; Almost identical intended uses and similar ingredient compositions. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document mentions "certain tests have been performed" on the peroxide component and "physical and technical characteristics...have been compared," but doesn't quantify the number of samples or specimens used for these comparisons or tests.
- Data Provenance: The manufacturer, Peroxid-Chemie, performed tests on the peroxide component. The overall comparison to the predicate was carried out by ESPE (the applicant). The manufacturing location (and thus likely the origin of some data) is implied to be Germany (ESPE's address is in Germany, and Peroxid-Chemie is mentioned as the manufacturer of the peroxide component). The data is retrospective in the sense that it's a comparison to an already cleared device and materials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. This application is for a material modification and relies on demonstrating equivalence through material properties and basic safety tests, rather than clinical performance interpreted by experts. There's no mention of experts establishing ground truth for performance.
4. Adjudication method for the test set
- Not applicable/Not specified. There is no mention of an adjudication process, as the tests described are primarily objective material property tests and general safety assessments, not clinical outcome 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 device is a dental filling material, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a dental filling material, not an algorithm.
7. The type of ground truth used
- The "ground truth" here is based on objective material properties (physical and technical characteristics) and established safety testing protocols (skin irritation, eye irritation, Ames, acute toxicity) for chemical components, as well as compliance with relevant DIN and ISO standards for dental composite materials. For the substantial equivalence claim, the "ground truth" is the performance and safety profile of the predicate device (Pertac®-Hybrid®).
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device, so there is no concept of a "training set" in the context of the provided information.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.