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K Number
K973247
Device Name
VINTAGE HALO
Manufacturer
SHOFU DENTAL CORP.
Date Cleared
1997-10-16

(48 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

Vintage HALO is a Dental Ceramic Fused-to-Metal Restorative Material.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental ceramic material called "VINTAGE HALO". It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

However, it does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Details about sample sizes for test sets, data provenance, or training sets.
  3. Information on expert involvement, ground truth establishment, or adjudication methods for any study.
  4. Data on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

The document is purely an administrative clearance letter and does not describe actual performance studies or their results in the way you've outlined.

§ 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.