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K Number
K071201
Device Name
ZEO CE LIGHT & ZEO QUICK PORCELAIN
Manufacturer
XPDENT CORP.
Date Cleared
2007-07-30

(91 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

Porcelain fused to metal for dental use.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) summary for a dental porcelain device. It is a regulatory document from the FDA outlining the substantial equivalence determination for "Zeo CE Light and Zeo Quick Porcelain."

This document does not contain information regarding:

  • Acceptance criteria and reported device performance.
  • Sample sizes, data provenance, or expert qualifications for a study.
  • Adjudication methods.
  • Multi-reader multi-case (MRMC) comparative effectiveness studies.
  • Standalone algorithm performance.
  • Types of ground truth used.
  • Training set sample sizes or how ground truth for training sets was established.

Therefore, I cannot provide the requested information based on the provided text. The document is strictly a regulatory approval notice and does not include the details of a performance study.

§ 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.