(88 days)
The Zmatch® Block is intended for CAD/CAM fabrication of all-ceramic dental restorations. The Zmatch® Block is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.
Zmatch® Block is a pre-formed machineable dental blank composed of zirconium oxide Zmatch® Block is available in partially-sintered Zmatch® Block is available in different shapes, and dimensions Zmatch® Block has two models that are Atype model and B-type model The difference between A-type and B-type is material composition. Zmatch® Block is a pre-formed ceramic dental blank intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations Zmatch® Block is designed for manufacturing ceramic dental restorations such as single crowns or bridgeworks The blank is machined by the customers/dental laboratories on their milling centers or similar equipment using CAD/CAM techniques for design.
This 510(k) summary describes a dental device, the Zmatch® Block, and asserts its substantial equivalence to predicate devices. However, it does not contain the information required to answer your specific questions regarding acceptance criteria and a study proving the device meets them.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Information on a test set (sample size, data provenance).
- Details about experts for ground truth or adjudication methods.
- A multi-reader multi-case (MRMC) comparative effectiveness study.
- A standalone algorithm performance study.
- The type of ground truth used.
- Information on a training set (sample size, ground truth establishment).
The purpose of this document is to demonstrate that the Zmatch® Block, a pre-formed machineable dental blank, is substantially equivalent to other legally marketed predicate devices (Sagemax Z-Blank, Cercon Base, LAVA Zirconia). This equivalence is based on similar intended use, material composition, biocompatibility, and biomechanical strength and properties, rather than performance metrics from a formal study against defined acceptance criteria.
Therefore, I cannot provide the requested information from the provided text.
§ 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.