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510(k) Data Aggregation

    K Number
    K170330
    Device Name
    3M Protemp Cement Temporary Dental Cement
    Manufacturer
    3M Company
    Date Cleared
    2017-02-06

    (4 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K003658
    Why did this record match?
    Device Name :

    3M Protemp Cement Temporary Dental Cement

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Temporary cementation of provisional restorations
    • Temporary cementation of final restorations
    Device Description

    3M™ Protemp™ Cement Temporary Dental Cement is a radiopaque, temporary cement used for temporary or provisional fixation of dental restorations. It is a selfcuring cement, with an option for tack light curing of any excess cement for ease of clean up. As a non-eugenol cement, Protemp™ Cement Temporary Dental Cement is suitable for use on patients with sensitivity to eugenol. Protemp™ Cement Temporary Dental Cement consists of a base and catalyst paste packaged in a proprietary automix delivery dispenser with a self-sealing cap. The automix delivery dispenser offers convenience over traditional hand mixed cements. Compared to leading automix systems, the proprietary delivery dispenser is designed to generate less waste and also has a lower extrusion force for ease of use. It is available in two shades. Opaque and Translucent.

    AI/ML Overview

    The provided document is a 510(k) summary for a dental cement (3M™ Protemp™ Cement Temporary Dental Cement) and does not describe an AI medical device. Therefore, it does not contain information about acceptance criteria, study designs, sample sizes, expert involvement, or other details relevant to AI device performance evaluation.

    The document discusses the substantial equivalence of the new dental cement to a predicate device (Temp-Bond™ NE) based on:

    1. Bench Testing: Evaluating properties such as working and setting times, bonding strength, film thickness, compressive strength, extrusion force, radiopacity, dimensional change, and fluoride release profile.
    2. Biocompatibility Testing: Assessed according to ISO standards like ISO 10993 and ISO 7405.

    Since the request pertains to an AI device and the provided document is not for an AI device, I cannot fulfill the request as specified.

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