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K Number
K974283
Device Name
PQ 1
Manufacturer
ULTRADENT PRODUCTS, INC.
Date Cleared
1998-01-29

(76 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

PQ 1 PermaQuick Bonding System is used for 95% of bonding needs in restorative dentistry. Ease of use I Q 1 t offinaQuick Donaling Cycleral as PQ 1 the agent of choice for all light cure bonding needs. PQ 1 is conducive for bonding to:

    1. Dentin and Enamel using composite or amalgam.
    1. Porcelain
    1. Metal
    1. Composite repair
Device Description

Not Found

AI/ML Overview

I apologize, but the provided text is a letter from the FDA regarding a medical device, not a study describing its acceptance criteria and performance. Therefore, I cannot extract the requested information, as the document does not contain details about:

  • Acceptance criteria and reported device performance in a table format.
  • Sample sizes, data provenance, number of experts, or ground truth establishment for test sets.
  • Adjudication methods.
  • MRMC comparative effectiveness studies or standalone algorithm performance.
  • Training set sample size or ground truth establishment.

The document primarily focuses on the FDA's substantial equivalence determination for the "PQ 1 PermaQuick Bonding System" and its intended uses.

§ 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.