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K Number
K193060
Device Name
Noritake Super Porcelain EX-3
Manufacturer
Kuraray Noritake Dental Inc.
Date Cleared
2020-01-30

(90 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

For use in prosthetic dentistry to create a Porcelain prosthesis on a frame of dental alloy.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a dental porcelain product. It does not contain any information about acceptance criteria, device performance testing, sample sizes, expert qualifications, or study methodologies that would be required to answer your request.

Specifically, it lacks the following:

  1. A table of acceptance criteria and reported device performance: This document only states the device "Noritake Super Porcelain EX-3" is cleared for "For use in prosthetic dentistry to create a Porcelain prosthesis on a frame of dental alloy." There are no performance metrics or criteria listed.
  2. Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, or how training ground truth was established. The letter is a regulatory approval, not a scientific study report.

Therefore,Based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria as the document is a regulatory approval letter and does not contain the detailed study information you are asking for.

§ 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.