(59 days)
Intended for preparation of crowns, facings, veneers, inlays and onlays--to produce a hard prosthesis with a porcelain-like finish.
For fabricating copings and frameworks for inlays, veneers, crowns, anterior and posterior bridge restorations.
Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.
Cynovad Zirkon™ is a zirconium dioxide-yttrium oxide ceramic, capable of machining by modern methods. The dentist prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay or onlay prepared by modern computerized lathe methods and returned to the dentist. The dentist then finally prepares the tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesives (luting) materials. Cynovad Zirkon™ inlays are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, except that their application more closely resembles gold inlays or porcelain inlays, onlays or veneers in that they are actually prepared in a dental laboratory. The material is radio-opaque, for ready visualization.
This submission describes a dental restorative material, "Cynovad Zirkon™", which is a zirconium dioxide-yttrium oxide ceramic used to create inlays, onlays, veneers, and crowns. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a study with specific acceptance criteria and performance metrics for the device itself.
Therefore, many of the requested sections (Table of acceptance criteria and performance, sample size for test set, number of experts, adjudication method, MRMC study, standalone study, ground truth type and training set information) cannot be extracted from the provided text as the information is not present.
Here's a breakdown of what can be inferred or stated from the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or performance metrics for the Cynovad Zirkon™ device. The entire submission is based on demonstrating substantial equivalence to legally marketed predicate devices, meaning its performance is considered acceptable if its technological characteristics and intended use are similar to those already cleared.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. There is no mention of a dedicated "test set" or a study designed to measure performance against specific criteria. The submission relies on a comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is mentioned as there is no human review of a test set described in the context of performance evaluation.
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 material for dental restorations, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader improvement with AI is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The basis for clearance is substantial equivalence to predicate devices, not direct comparison to a clinical ground truth established through expert consensus, pathology, or outcomes data for the Cynovad Zirkon™ itself. The "ground truth" in this context is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable. As a material, there is no "training set" in the context of algorithm development.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.