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K Number
K173275
Device Name
OMNICHROMA
Manufacturer
Tokuyama Dental Corporation
Date Cleared
2018-02-27

(138 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
K121583,K112501,K080940,K051808,K161353,K010267
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For use as a tooth shade resin material in dental procedures, such as:

  • Direct anterior and posterior restorations
  • Direct bonded composite veneer
  • Diastema closure
  • Repair of porcelain/composite
Device Description

The OMNICHROMA device is a light-cured, radiopaque composite resin for use in anterior and posterior restorations and is indicated for all carious classes. The OMNICHROMA device is available in only one shade.

The device does not come sterilized and is not intended to be sterilized prior to use.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the OMNICHROMA tooth shade resin material. It does not contain information about a comparative effectiveness study involving AI or human readers, nor does it detail acceptance criteria and performance data in the context of an AI device. The document is for a dental restorative material, not an AI-powered diagnostic or assistive device.

Therefore, I cannot fulfill your request for:

  • A table of acceptance criteria and reported device performance related to an AI device.
  • Sample sizes, data provenance, and expert details for a test set for an AI device.
  • Adjudication methods for an AI device's test set.
  • MRMC study details or effect sizes for human readers with/without AI assistance.
  • Standalone performance for an AI algorithm.
  • Ground truth types in the context of AI.
  • Training set sample size and ground truth establishment for an AI device.

The provided document focuses on the physical and chemical properties of a dental resin and its substantial equivalence to a predicate device based on non-clinical testing according to ISO 4049. There is no mention of AI, diagnostic performance, or human reader studies.

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.