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510(k) Data Aggregation

    K Number
    K042804
    Device Name
    TESCERA OPAQUER POWDER/SCULPTING RESIN
    Manufacturer
    BISCO, INC.
    Date Cleared
    2005-02-01

    (112 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K874557,K030585
    Why did this record match?
    Device Name :

    TESCERA OPAQUER POWDER/SCULPTING RESIN

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

    TESCERA Opaquer/Sculpting Resin is a pre-wetting agent for placing and sculpting layers of composites.

    When mixed with TESCERA Opaquer Powder, TESCERA Opaquer/Sculpting Resin is a dual-cured material (light/heat) used to opaque/mask metal substrates and other materials used in dental restorations.

    Device Description

    TESCERA Opaquer/Sculpting Resin is a dual-cured (light/heat), low viscosity resin for used for wetting composite instruments. With TESCERA Opaquer Powder, TESCERA Opaquer/Sculpting Resin is a dual-cured (light/heat) tooth colored opaquing/masking composite system specially formulated to opaque/mask the substrates used in dental restorations.

    AI/ML Overview

    This document describes a 510(k) premarket notification for a dental device, comparing it to predicate devices. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through empirical testing with a defined sample size, ground truth, or expert evaluation.

    The provided text focuses on establishing substantial equivalence based on intended use, chemical composition, and mechanical/physical properties compared to existing legally marketed devices, rather than a clinical or performance study with defined acceptance criteria.

    Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets those criteria because the provided text does not contain this type of data.

    Specifically, the document states: "Side by side comparisons of TESCERA Opaquer/Sculpting Resin and Opaquer Powder to the predicate devices D/C OPAQUER and MODELING RESIN clearly demonstrate that the applicant device is substantially equivalent to the legally marked devices. TESCERA Opaquer/Sculpting Resin and Opaquer Powder were tested for biocompatibility and they were found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of TESCERA Opaquer/Sculpting Resin and Opaquer Powder." This indicates a comparison for substantial equivalence and biocompatibility testing, not a performance study with acceptance criteria.

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