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K Number
K980058
Device Name
TOKUSO MAC BOND II
Manufacturer
TOKUYAMA AMERICA, INC.
Date Cleared
1998-04-27

(111 days)

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

For use in dental procedures as a bonding primer with light cured resin filling material to enhance the adhesion of resin filling material to the tooth

Device Description

The product is a tooth enamel/dentin bonding resin for use with Tokuyama's Tokuso Estelite or other types of light cured composite resins to enhance the bonding of these materials to the tooth. It may be used in anterior and posterior applications. After mixing and applying the primer and allowing it to dry, as directed, the bonding agent is applied to the whole cavity preparation. After air drying, the bonding agent is cured with currently marketed visible light curing devices.

AI/ML Overview

This document is a 510(k) premarket notification for a dental bonding agent, Tokuso Mac Bond II. It confirms the device's substantial equivalence to previously marketed devices and permits its market entry. However, the document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the provided text lacks this specific data.

The document primarily focuses on:

  • Device Identification: Tokuso Mac Bond II, a resin tooth bonding agent.
  • Intended Use: As a bonding primer with light-cured resin filling material to enhance adhesion to the tooth in dental procedures (anterior and posterior applications).
  • Predicate Devices: Tokuso Light Bond, Scotchbond Adhesive System, Clearfil Liner Bond 2.
  • Regulatory Information: Classified as Class II, Product Code EBF.
  • Safety Information: Contains common dental materials, contraindicated for methacrylate monomer hypersensitivity, precautions for skin/eye contact, and flammability.

To answer your specific questions, information from a different part of the 510(k) submission (e.g., performance data, bench testing results, clinical study reports) would be necessary.

§ 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.