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510(k) Data Aggregation

    K Number
    K190930
    Device Name
    SmarTemp X1
    Manufacturer
    Parkell, Inc.
    Date Cleared
    2019-09-05

    (148 days)

    Product Code
    EBG,POW
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K101710
    Why did this record match?
    Device Name :

    SmarTemp X1

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SmarTemp® X I is a self-curing composite for the fabrication of temporary crowns and bridges, inlays and veneers. SmarTemp® X1 is intended for the fabrication of: temporary crowns, bridges, inlays, long-term temporaries, and temporary veneers.

    Device Description

    SmarTemp® X1 is a self-curing, resin-based composite, suitable for the fabrication of temporary crowns, bridges, inlays, onlays, and veneers. It is a bis-acryl resin-based material comprising a 10:1 ratio of base to catalyst components, which when expressed by the user from dual-chamber syringes or cartridges mix through standard snap-in accessory mixing tips. SmarTemp® X1 self-cures in approximately 6 minutes at mouth temperature.

    SmarTemp® X1 is packaged in any standard, opaque, dual-chamber syringe or cartridge suitable for containing a 10:1 ratio of base and catalyst components, respectively. The syringe or cartridge is accompanied by standard snap-in automix tips.

    AI/ML Overview

    The provided text describes the regulatory clearance of a dental material, SmarTemp X1, as substantially equivalent to a predicate device, Luxatemp Ultra/Star. It does not contain information about a clinical study or acceptance criteria related to an AI/ML powered medical device.

    However, based on the provided document, I can extract information related to the acceptance criteria and testing for the SmarTemp X1 dental material, which serves as a substitute for the requested AI/ML device information.

    Here's the breakdown of the acceptance criteria and the study (bench performance testing) for SmarTemp® X1:

    SmarTemp® X1 Acceptance Criteria and Bench Performance Study

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for SmarTemp® X1 appear to be based on demonstrating equivalence or meeting certain thresholds compared to the predicate device, Luxatemp® Ultra/Star, for critical physical properties.

    PropertyAcceptance Criteria (Predicate Device K101710)Reported Device Performance (SmarTemp® X1)
    Compressive Strength>300 MPa>300 MPa
    Flexural Strength>100 MPa>100 MPa
    Shrinkage
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