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K Number
K043468
Device Name
WILLI GELLER CREATION II PORCELAIN
Manufacturer
JENSEN INT'L, INC.
Date Cleared
2005-01-12

(27 days)

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

Willi Geller Creation TI Porcelain is a ceramic material intended for veneering of titanium alloy cores and substructures to form dental restorations.

Device Description

Williw Geller Creation TI porcelain is a dental ceramic that is used by dental technicians to fabricate dental restorations by veneering of titanium alloy cores. Data has been presented to demonstrate that the mechanical properties, chemical qualities, and the indications for use make Willi Geller Creation TI substantially equivalent to the predicate device Willi Geller Creation& LF Porcelain. The safety and effectiveness of Willi Geller Creation TI , being determined by the chemical qualities and mechanical properties, is therefore equivalent to the predicate devices.

AI/ML Overview

The provided document, K043468, is a 510(k) summary for a dental porcelain device. It focuses on demonstrating substantial equivalence to a predicate device based on mechanical properties, chemical qualities, and indications for use.

Therefore, the document does not contain information on the following:

  • Acceptance criteria or reported device performance in a table format for a diagnostic or AI device.
  • Sample sizes, data provenance, or details about test sets.
  • Number of experts, their qualifications, or adjudication methods for establishing ground truth.
  • Multi-reader multi-case (MRMC) comparative effectiveness studies or human reader improvement with AI.
  • Standalone algorithm performance.
  • Types of ground truth (e.g., pathology, outcomes data).
  • Sample size for training sets or how ground truth was established for training sets.

Instead, the document states:

Acceptance Criteria and Study:

The acceptance criteria for "Willi Geller Creation TI Porcelain" were based on demonstrating substantial equivalence in:

  • Mechanical properties
  • Chemical qualities
  • Indications for use

The study performed to prove the device meets these acceptance criteria was a comparison to a predicate device, Willi Geller Creation& LF Porcelain (K00290). The submission asserts that "Data has been presented to demonstrate that the mechanical properties, chemical qualities, and the indications for use make Willi Geller Creation TI substantially equivalent to the predicate device Willi Geller Creation& LF Porcelain."

The safety and effectiveness of "Willi Geller Creation TI" were determined by these chemical qualities and mechanical properties, making it equivalent to the predicate devices.

§ 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.