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510(k) Data Aggregation

    K Number
    K972844
    Device Name
    TEMP BOND CLEAR
    Manufacturer
    KERR DENTAL MATERIALS CENTER
    Date Cleared
    1997-10-03

    (63 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Kerr Temp Bond Clear Temporary Cement is indicated for use for temporary crown and bridge cementation procedures.

    Device Description

    Kerr's Temp Bond Clear is designed to fulfill all of the requirements of a successful temporary restorative cementation material. These requirements are itemized below.

    1. Ease of placement. Kerr Temp Bond Clear handles very similarly to the ZOE cements alresdy familiar to dentists.
    2. Convenience. The chemical cure characteristics of Temp Bond Clear provide for a quick and simple procedure,
    3. Aesthetics. The highly translucent nature of Temp Bond Clear provides a pleasing, tooth-like appearance even when margins are exposed.
    4. Strength. The glass reinforced resin resists mastication forces that would fracture a ZOE type cement.
    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for Kerr Temp Bond Clear Temporary Cement:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document defines "efficacy" as "suitability to the intended purpose," which is demonstrated by a combination of in-house testing and side-by-side comparisons to predicate devices. The acceptance criteria are implicitly set by the performance of predicate devices already on the market (Temp Bond ZOE in this case), with the goal of performing "as well or better."

    Acceptance Criteria (Implicit, based on Predicate Device Performance)Reported Device Performance (Temp Bond Clear)
    Diametral Tensile Strength @ 24 hr.4285 psi (Better than Temp Bond ZOE)
    Water Solubility0.5 % (Better than Temp Bond ZOE)
    Film Thickness
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