(161 days)
Used as a permanent restorative material in all cavity classes for both permanent and deciduous teeth; as a base material underneath amalgams, ceramics, cast metal restorations, and composites; as a laminate or open sandwich technique; for root canes lesions; and for core build-up
DYRACT® AP RESTORATIVE is a one-component, visible light curing, dental restorative material, delivered in COMPULES®, which hardens upon polymentation. The composition is polymenzed by brief exposure to visible light from a dental curing light. When polymenzation occurs, the monomers cross-link to form polymer-containing carboxyl groups which are capable of further reaction with cations eluted from the glass-reinforcing filler to form a salt, as in DYRACT® II Restorative (K950991). The modifications to the DYRACT II Restorative serve to enhance the strength and wear resistance of DYRACT AP RESTORATIVE.
This document is a 510(k) Summary for a dental restorative material, not a study evaluating a device using "acceptance criteria" in the typical sense of statistical performance metrics. It's a premarket notification for a Class II medical device (DYRACT® AP RESTORATIVE) to demonstrate substantial equivalence to a predicate device (DYRACT® II Restorative).
Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this document, as they are not applicable to the format and content of a 510(k) summary focused on substantial equivalence based on material properties and intended use.
However, I can provide information based on what is present in the document.
Summary based on the provided document:
The document describes DYRACT® AP RESTORATIVE, a one-component, visible light-curing, dental restorative material. The core of the submission is to demonstrate its substantial equivalence to a predicate device, DYRACT® II Restorative (K950991). The modifications to the DYRACT® II Restorative "serve to enhance the strength and wear resistance of DYRACT AP RESTORATIVE."
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in terms of statistical thresholds for clinical performance metrics (e.g., sensitivity, specificity, AUC). Instead, it relies on the similarity of physical properties and safety testing to establish substantial equivalence.
| Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Physical Properties | Similar to the predicate device (DYRACT® II Restorative) | "The physical properties of DYRACT AP RESTORATIVE and the predicate device are similar." (No specific values or metrics are provided in this summary, but this is the claim made to demonstrate equivalence). The modifications enhance strength and wear resistance, implying improvement while maintaining overall similarity. |
| Biocompatibility/Safety | Non-mutagenic and non-sensitizing | Cured material was tested by the Ames Mutagenicity Test and Guinea Pig Sensitization Test. The cured material is reported as non-mutagenic and a non-sensitizer. |
| Components | Components have been used in legally marketed devices or found safe for dental use. | "All components in DYRACT AP RESTORATIVE have been used in legally marketed devices or found to be safe for dental use." |
| Intended Use | Same as or similar to the predicate device, for specific dental restorative applications. | Stated intended uses: permanent restorative in all cavity classes (permanent & deciduous teeth), base material, laminate/open sandwich, root caries, core build-up. (No direct comparison to predicate intended use provided in this summary, but implied to be equivalent or enhanced). |
2. Sample Size for Test Set and Data Provenance:
The document does not describe a "test set" in the context of diagnostic or AI device evaluation. It is referring to material property testing and safety testing.
- Sample Size: Not specified for physical property comparisons or for the Ames Mutagenicity Test and Guinea Pig Sensitization Test.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This type of information is typically not included in a 510(k) summary for material science testing.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. This is not a study requiring expert readers or ground truth establishment in a clinical imaging context. The evaluation is focused on material properties and safety.
4. Adjudication Method:
Not applicable. This is not a study requiring adjudication of expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not a study involving human readers or AI assistance in a diagnostic context.
6. Standalone (Algorithm Only) Performance:
Not applicable. This is a dental material, not an algorithm or software device.
7. Type of Ground Truth Used:
Ground truth in this context would implicitly be laboratory measurements for physical properties (e.g., strength, wear resistance) and validated biological assays for safety (Ames test, sensitization test). No clinical "ground truth" (e.g., pathology, outcomes data) is mentioned in this summary as the basis for performance evaluation, as the device is not a diagnostic tool requiring such validation.
8. Sample Size for the Training Set:
Not applicable. This is a dental material; there is no "training set" as understood in machine learning or AI.
9. How Ground Truth for the Training Set was Established:
Not applicable. There is no training set for this device.
§ 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.