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DYRACT® FLOW RESTORATIVE is used for: Filling of defects and undercuts in crowns, inlays; Liner under direct restorative materials and under inlay restorations-Class II box liner; Tunnel preparations; Pit and fissure sealants; Amalgam margin repair; Improving margins of acrylic temporaries; Small class IV repairs; Intraoral porcelain repair; Cementing porcelain veneers, crowns, inlays/onlays; Refacing acrylic temporaries; Blockouts; Covering incisal edge stains; Repair of small enamel defects; Provisional occlusal changes; Class III, V restorative Class I restorations; and Margin correction/adjustment of composite crowns for indirect laboratory use.

DYRACT® FLOW RESTORATIVE is a one-component, moderately filled, visible light cured dental composite restorative material. DYRACT® FLOW RESTORATIVE is a low viscosity, esthetic material for use as a composite restorative. It is a moderately filled, radiopaque, fluoride-releasing composite, primarily designed for restoration of shallow defects such as incipient Class V lesions.

The document is a 510(k) summary for the DENTSPLY DYRACT® FLOW RESTORATIVE, a dental composite material. The device's acceptance criteria and the study proving it meets these criteria are outlined in section:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

The document does not provide details on the sample size used for testing or the data provenance specifically for the DYRACT® FLOW RESTORATIVE. It states that the physical properties meet ISO Standard 4049.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

This information is not provided in the supplied text. The evaluation is based on meeting an international standard (ISO 4049), which implies standardized testing procedures rather than expert ground truth establishment in a clinical context.

4. Adjudication method for the test set:

This information is not provided in the supplied text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

No MRMC comparative effectiveness study is mentioned in the document. The submission focuses on the material's physical properties meeting an ISO standard and its components being used in predicate devices.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the device is a dental restorative material, not an AI or software device.

7. The type of ground truth used:

The ground truth used for proving the device meets its acceptance criteria is compliance with ISO Standard 4049 for physical properties. This is a technical standard, not a clinical ground truth like pathology or outcomes data.

8. The sample size for the training set:

This information is not applicable as the device is a dental restorative material, not an AI or software device requiring a training set in that context. The "training" in this context would refer to the development and formulation of the material.

9. How the ground truth for the training set was established:

This information is not applicable in the context of an AI training set. The development of the dental restorative material would have involved material science and chemical engineering principles, with "ground truth" being established through iterative testing and formulation to achieve desired physical and chemical properties and biocompatibility. The document notes that "All of the components found in DYRACT® FLOW RESTORATIVE have either been used in predicate dental devices or have been found safe for dental use," and that "prior use of the components... performance data, and the biocompatibility data provided support the safety and effectiveness." This suggests that previous research and testing on individual components contributed to the "ground truth" for developing the final device.

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