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K Number
K974786
Device Name
PREPQUICK
Manufacturer
ULTRADENT PRODUCTS, INC.
Date Cleared
1998-03-03

(71 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
Dental
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

PrepQuick has shown to be an effective means for selective removal of smear layer prior to cementation, e.g., glass ionomers and polycarboxylate cements or restoratives.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "PrepQuick." It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria. The letter is a regulatory approval, not a scientific study report.

Therefore, I cannot provide the requested information. The sections of your request remain unanswered based on the provided text:

  1. A table of acceptance criteria and the reported device performance: Not provided in the document.
  2. Sample size used for the test set and the data provenance: Not provided in the document.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the document.
  4. Adjudication method: Not provided in the document.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not relevant, as this is not an AI/imaging device and no human reader study is mentioned.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant, as this is not an algorithm/software device.
  7. The type of ground truth used: Not provided in the document.
  8. The sample size for the training set: Not provided in the document.
  9. How the ground truth for the training set was established: Not provided in the document.

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.