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K Number
K983668
Device Name
MODIFICATION OF PQ1
Manufacturer
ULTRADENT PRODUCTS, INC.
Date Cleared
1998-11-30

(42 days)

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

Use for almost all bonding needs in restorative dentistry. Ease of use and unsurpassed bond strength in a single syringe primer/ocnding resin makes PQ1 the agent of choice for most light cure bonding needs. Also use PQ1 with chemical sure luting and chemical cure composite (e.g. Permalute). PQ1 is conducive for bonding to:

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

Modification of PQ1

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a dental bonding agent named "PQ1" (or "PO1" in one instance), with a submission number K983668. This document outlines the FDA's decision regarding the substantial equivalence of the device but does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request for the specific details about the acceptance criteria and the study that proves the device meets them based solely on the provided text.

The document indicates:

  • Device Name: PQ1 (also listed as PO1)
  • 510(k) Number: K983668
  • Indications for Use: For almost all bonding needs in restorative dentistry, including bonding to dentin, enamel, porcelain, metal, and for composite repair. It is also used with chemical cure luting and chemical cure composite.

To answer your questions, I would need access to the actual 510(k) submission document (K983668) from Ultradent Products, Incorporated, which would contain the performance data and details of any studies conducted.

§ 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.