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K Number
K193434
Device Name
VITA LUMEX AC
Manufacturer
VITA Zahnfabrik GmbH H Rauter & Co
Date Cleared
2020-07-21

(223 days)

Product Code
EIH
Regulation Number
872.6660
Type
Traditional
Panel
DE
Reference & Predicate Devices
K060441
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

VITA Lumex® AC is used to veneer the following:

  • Full and partial veneering of zirconia
  • Full and partial veneering of lithium disilicate
  • Partial veneering of feldspar ceramic
  • Reconstruction without a substructure
    Materials:
  • Zirconia substructures (CTE approx. 10.0 to 10.5 x 10-6 K-1)
  • Glass-ceramic substructures (CTE approx. 9.0 to 10.5 x 10-6 K-1)
Device Description

VITA Lumex® AC is a natural low-fusing veneering ceramic system that is suitable for veneering all ceramic substructures. VITA LUMEX AC standard layering consists of the two Materials DENTINE and ENAMEL. The color-bearing DENTINE materials, which provide good coverage, offer the perfect precondition for the preparation of veneers with intensive shades. With this two-layer alternative, VITA offers an ideal solution for the reproduction of optimal shade results in case of thin walls. Additionally, the intensive shade effect of the DENTINE permits a more generous use of the ENAMEL materials, which create the desired translucency. The user is able to prepare a natural restoration with a lifelike appearance with only two layers. This product is provided non-sterile in glass jars in a powder form to be used in conjunction with the Vita low fusing liquid.

AI/ML Overview

This document is a 510(k) Premarket Notification for the VITA Lumex® AC, a porcelain powder for clinical use, and not a study describing the acceptance criteria and performance of a device that meets those criteria.

Therefore, I cannot provide the requested information, which includes:

  • A table of acceptance criteria and reported device performance.
  • Sample size used for the test set and data provenance.
  • Number of experts and their qualifications for establishing ground truth.
  • Adjudication method for the test set.
  • MRMC comparative effectiveness study results.
  • Standalone (algorithm-only) performance.
  • Type of ground truth used.
  • Sample size for the training set.
  • How ground truth for the training set was established.

The document states: "Non-Clinical Performance Testing" on page 5, indicating that "Bench test results allowed us to conclude that VITA Lumex® AC is substantially equivalent to the predicate device for its intended use." It also explicitly states "Clinical Performance Data: Not applicable. No human clinical testing was performed to support the substantial equivalence of VITA Lumex® AC."

This filing relies on bench testing and comparison to predicates, not specific clinical performance studies with acceptance criteria as requested in your prompt.

§ 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.