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K Number
K050160
Device Name
KATANA ZIRCONIA
Manufacturer
NORITAKE CO., INC.
Date Cleared
2005-02-07

(13 days)

Product Code
EIH
Regulation Number
872.6660
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

KATANA Zirconia is intended for CAD/CAM fabrication of zirconia frameworks for allceramic dental restorations.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a dental device called "Katana Zirconia." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding:

  • Acceptance criteria or reported device performance metrics in a table.
  • Sample sizes for test or training sets, nor their provenance.
  • Number or qualifications of experts used for ground truth.
  • Adjudication methods.
  • Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
  • Standalone (algorithm-only) performance studies.
  • Type of ground truth used.
  • How ground truth for the training set was established.

This document is a regulatory approval, not a scientific study report or technical specification outlining testing details. Therefore, I cannot provide the requested information based on the input 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.