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K Number
K990790
Device Name
VISION PORCELAIN
Manufacturer
SERVO DENTAL USA, INC.
Date Cleared
1999-04-02

(23 days)

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

Vision Porcelain is used in fabrication of crowns Inlays, Veneers and bridges.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for "Vision Porcelain," which is a dental material used in the fabrication of crowns, inlays, veneers, and bridges. This document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval document confirming substantial equivalence to a predicate device.

Therefore, I cannot extract any of the requested information, such as:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes for test sets or data provenance.
  • Number and qualifications of experts.
  • Adjudication methods.
  • Results of multi-reader multi-case studies.
  • Standalone algorithm performance.
  • Type of ground truth used.
  • Training set sample size or ground truth establishment.

§ 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.