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K Number
K163346
Device Name
MAZIC Duro
Manufacturer
VERICOM CO., LTD.
Date Cleared
2017-03-17

(108 days)

Product Code
EBF,POW
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
K133824
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Fabrication of inlays, onlays, veneers and crowns

Device Description

MAZIC™Duro, a dental restorative material, is a radiopaque, block type, hybrid ceramic that is intended for the fabrication of inlays, onlays, veneers and crowns. The device can be matched to the patient's tooth shade and is intended for use in dental CAD/CAM milling procedures.

AI/ML Overview

The provided text describes the 510(k) summary for the dental device MAZIC™ Duro, which is a tooth shade resin material. It focuses on demonstrating substantial equivalence to a predicate device (CERASMART) rather than proving performance against specific acceptance criteria for an AI/algorithm-based medical device.

Therefore, the requested information regarding acceptance criteria, study design for AI evaluation (sample size, ground truth establishment, expert adjudication, MRMC studies, standalone performance), and training set details cannot be extracted from this document, as it is not relevant to an AI/algorithm-based device. The document describes a physical material, and its performance is evaluated through material properties and biocompatibility as opposed to AI accuracy metrics.

The document states:

  • Device Type: MAZIC™ Duro is a "radiopaque, block type, hybrid ceramic that is intended for the fabrication of inlays, onlays, veneers and crowns." It's a dental restorative material used in CAD/CAM milling procedures.
  • Performance Testing: "MAZIC™ Duro and the predicate device, CERASMART were tested for the nonclinical performance including compressive strength, flexural strength, elastic modulus, radio-opacity, vicker's micro hardness, water sorption, and solubility."
  • Biocompatibility: Evaluated according to ISO 10993 standards.

Since the request is specifically about "acceptance criteria and the study that proves the device meets the acceptance criteria" for an AI/algorithm-based device, and this document pertains to a physical dental material, the requested information is absent.

§ 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.