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K Number
K060844
Device Name
SILKLINE SOFT RELINING KIT, MODEL 28-100100
Manufacturer
J. MORITA USA, INC.
Date Cleared
2006-06-06

(70 days)

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

The SilkLine Soft Relining Kit is intended to be used as a denture relining, repairing, or rebasing resin.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a dental device called "SilkLine Soft Relining Kit." This document does not describe acceptance criteria for a device, nor does it detail a study that proves the device meets such criteria.

The information provided is a clearance letter from the FDA indicating that the device has been found substantially equivalent to a legally marketed predicate device. This process, known as 510(k) clearance, is primarily about demonstrating equivalency to existing devices, not about establishing specific performance metrics against pre-defined acceptance criteria through a clinical study as would be detailed for a novel device or AI-powered system.

Therefore, I cannot provide the requested information as it is not present in the given text.

To address the specific points you requested:

  1. A table of acceptance criteria and the reported device performance: Not available in the text.
  2. Sample size used for the test set and the data provenance: Not available in the text.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in the text.
  4. Adjudication method: Not available in the text.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not available in the text. This type of study is more common for diagnostic AI devices, not for a dental relining kit.
  6. If a standalone performance study was done: Not available in the text.
  7. The type of ground truth used: Not applicable for this type of device clearance and not mentioned.
  8. The sample size for the training set: Not applicable (no AI/algorithmic training mentioned).
  9. How the ground truth for the training set was established: Not applicable.

§ 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.