LogoFDA 510(k) Search
K Number
K012174
Device Name
ERIS LAYERING MATERIALS
Manufacturer
IVOCLAR NORTH AMERICA, INC.
Date Cleared
2001-08-27

(46 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

Eris Layering materials are porcelain powders used in our pressable ceramic system, Eris Layering materials are personal free single unit, and multiple unit bonded crown and bridge restorations.

Device Description

Eris Layering materials are porcelain powders used in our pressable ceramic system

AI/ML Overview

I am sorry, but the provided text is a standard FDA 510(k) clearance letter for a dental material (Eris Layering Materials). It establishes substantial equivalence to a predicate device and permits marketing.

The document does not contain any information about:

  • Acceptance criteria for the device's performance.
  • Any study that proves the device meets specific acceptance criteria.
  • Device performance data.
  • Sample sizes for test or training sets.
  • Data provenance.
  • Number or qualifications of experts.
  • Adjudication methods.
  • MRMC comparative effectiveness studies.
  • Standalone algorithm performance.
  • Type of ground truth used.
  • How ground truth was established.

Therefore, I cannot provide the requested information based on the input text.

§ 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.