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K Number
K022641
Device Name
TOKUYAMA REBASE II
Manufacturer
TOKUYAMA AMERICA, INC.
Date Cleared
2002-10-02

(55 days)

Product Code
EBI
Regulation Number
872.3760
Type
Traditional
Panel
DE
Reference & Predicate Devices
K896981
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For relining denture surfaces, to repair a fractured denture, or to form a new denture base.

Device Description

The product is a chairside denture relining material for relining, repairing and rebasing removable dentures. It is substantially equivalent to the company's Tokuso Rebase (K896981). The product is offered in two versions of differing in curing time; i.e., Fast and Normal. The product complies with ADAS No. 17 and has been approved for marketing by the Japanese Ministry of Health and Welfare.

AI/ML Overview

The provided text describes a 510(k) submission for a dental device, "Tokuyama Rebase II," but it does not contain any information regarding acceptance criteria, device performance, a study, or any of the specific details requested in your prompt (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).

This document is a regulatory submission for a dental relining material, primarily focused on establishing substantial equivalence to a legally marketed predicate device (Tokuso Rebase K896981) and its conformity to ADAS No. 17 standards. It lists the device's intended use and contraindications, but it does not include performance data or a study report in the format you've requested.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance.
  3. Number or qualifications of experts.
  4. Adjudication method.
  5. MRMC comparative effectiveness study results or effect size.
  6. Standalone performance details.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 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.