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K Number
K033049
Device Name
CZR PRESS
Manufacturer
NORITAKE CO., INC.
Date Cleared
2003-10-24

(25 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 an all-ceramic prosthesis

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Noritake Company, Incorporated regarding their CZR Press device. This letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed.

However, the letter does not contain any information about:

  • Acceptance criteria or reported device performance metrics.
  • Details of any study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input. The document is primarily an FDA clearance letter, not a detailed study report.

§ 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.