LogoFDA 510(k) Search
K Number
K030663
Device Name
TOKUYAMA SOFRELINER TOUGH
Manufacturer
TOKUYAMA DENTAL CORPORATION
Date Cleared
2003-05-29

(87 days)

Product Code
EBI
Regulation Number
872.3760
Type
Traditional
Panel
DE
Reference & Predicate Devices
K982537,K953589,K990736,K940566
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The product is a denture relining resin material for use in relining the tissue contact sur ace cf dentures (21 CFR 872.3760). For use as a denture reliner.

Device Description

The product is a denture relining resin material for use in relining the tissue contact sur ace cf dentures (21 CFR 872.3760)

AI/ML Overview

The provided text is related to a 510(k) submission for a denture relining resin material, Tokuyama SOFRELINER TOUGH. It primarily focuses on the regulatory approval process, stating that the device is substantially equivalent to existing predicate devices.

The document does NOT contain information regarding:

  • Specific acceptance criteria for device performance (e.g., tensile strength, tear resistance, bonding strength, hardness, water absorption).
  • Details of any study that proves the device meets specific acceptance criteria.
  • Sample sizes used for test sets or training sets.
  • Data provenance.
  • Number or qualifications of experts.
  • Adjudication methods.
  • Multi-reader multi-case (MRMC) comparative effectiveness studies.
  • Standalone algorithm performance.
  • Type of ground truth used.
  • How ground truth for the training set was established.

Therefore, I cannot fulfill your request to describe acceptance criteria and study details with the provided input.

The document states: "It contains materials that are common in dental use and pose no health hazard when used according to directions. It is substantially equivalent to various marketed denture relining products..." This implies that the device's performance characteristics are expected to be similar to legally marketed predicate devices, but the text does not present the specific data or studies to demonstrate this.

To answer your request, you would need a different document, likely a performance testing report or a clinical trial summary, which is not present in the provided 510(k) summary and FDA letter.

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.