(81 days)
Intended for use in preparation of crowns, facings, inlays and onlays--to produce a hard prosthesis with a porcelain-like finish. Frequently used with porcelain overlay for translucence and related effects. For fabricating copings and frameworks for inlays, onlays, 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.
Zirl3lank-PS and ZirBlank-FS is a yttrium oxide-stabilized zirconia (Y-ITZP) 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, onlay or other prosthesis is prepared by modern computerized lathe methods and returned to the dentist. The dentist then prepares the final tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesives (luting) materials. ZirBlank-PS and ZirBlank-FS prostheses are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, more closely resembling 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 does not contain information about an AI/ML device or a medical device that would have acceptance criteria and a study to prove it meets them in the typical sense of diagnostic performance metrics (e.g., sensitivity, specificity).
The document is a 510(k) summary for a dental restorative material, ZirBlank-PS and ZirBlank-FS, which are yttrium oxide-stabilized zirconia (Y-TZP) powders/blocks. The purpose of a 510(k) submission for such a device is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove diagnostic performance.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes for test/training, expert details, adjudication methods, MRMC studies, standalone performance, or ground truth types) because this type of evaluation is not applicable to this particular device and its regulatory submission.
The "study" mentioned in the document refers to the demonstration of substantial equivalence based on:
- Same intended use as predicate devices.
- Similar technological characteristics, with well-understood differences.
- Well-established materials (components of ZirBlank-PS and ZirBlank-FS have prior successful use in legally marketed devices, including hip implants).
- Comparison to predicate devices for safety and effectiveness.
The "acceptance criteria" here are implicitly satisfying the FDA's requirements for substantial equivalence, primarily by demonstrating that the device is as safe and effective as predicate devices. The performance is assessed by material properties and intended use, not by diagnostic accuracy.
§ 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.