(22 days)
Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, V (Inlays and Onlays) and as a restorative material intended for veneers, crowns, and bridges
DDS-ZR is a Zirconia hybrid ceramic ideally suited for computerized dental machining applications. The dental professional prepares the appropriate tooth, sends a traditionally prepared impression to the lab where the restoration is produced, computer machined, and then returned to the dentist for placement. The dentists practice traditional luting/cementing techniques to permanently place the inlay or onlay. DDS-ZR is an alternative to gold, amalgam, porcelain, or composite filling materials, except that its application more closely resembles gold inlays or porcelain inlays or veneers used in a dental laboratory. The material is radioopaque, for ready visualization.
This document describes a 510(k) premarket notification for a dental restorative material, DDS-ZR, a Zirconia hybrid ceramic. The approval is based on substantial equivalence to predicate devices, not on a study demonstrating device performance against specific acceptance criteria. Therefore, most of the requested information cannot be extracted from the provided text.
Here's an explanation of why each requested point cannot be fully addressed:
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A table of acceptance criteria and the reported device performance:
- The document does not specify quantitative acceptance criteria for device performance (e.g., specific thresholds for strength, durability, wear resistance).
- It also does not report specific performance data for DDS-ZR. The approval is based on the material "Zirconia" having been "repeatedly tested throughout the medical and dental literature and research" and found to be "highly biocompatible," and that the material is "well known to the dental industry." This is a qualitative statement about the material class, not specific performance of the device against predefined criteria.
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Sample sized used for the test set and the data provenance:
- No test set for performance evaluation is described. The approval is based on the known properties of Zirconia as a material and its similarity to existing legally marketed devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no specific test set requiring expert ground truth establishment is described.
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Adjudication method for the test set:
- Not applicable, as no specific test set requiring expert adjudication is described.
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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 a dental material, not an AI-assisted diagnostic or imaging device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a dental material, not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this approval is the established knowledge and literature regarding Zirconia's biocompatibility and mechanical properties in dental applications, as well as the substantial equivalence to predicate devices. There isn't a specific "ground truth" derived from a clinical study for this device.
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The sample size for the training set:
- Not applicable, as there is no mention of a training set for an algorithm.
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How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set or its ground truth establishment.
Summary based on available information:
The provided text is a 510(k) summary for a dental restorative material (DDS-ZR). The approval is based on "substantial equivalence" to predicate devices and the general understanding of the material (Zirconia) in the dental industry. It focuses on the material's characteristics, intended use, and similarity to existing products rather than presenting data from a dedicated performance study with defined acceptance criteria. Therefore, the requested details regarding acceptance criteria, study design, sample sizes, and expert adjudication are not present in this type of regulatory document.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.