LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K032106
    Device Name
    STARBOND DENTAL BONDING ALLOYS
    Manufacturer
    STAR REFINING PRECIOUS METALS SOUTH AFRICA
    Date Cleared
    2003-08-25

    (48 days)

    Product Code
    EJT,EJS
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    STARBOND SISG: Porcelain to precious metal alloy suitable for single units, short and long span bridges for metal ceramics, as well as milled work and implant over structures.
    STARBOND S250: Porcelain to precious metal alloy suitable for single units, short and long span bridges for metal ceramics, as well as milled work and implant over structures.
    STARBOND 575P: Porcelain to precious metal alloy suitable for single units, short and long span bridges for metal ceramics, as well as milled work, bars and attachments and cast partial dentures.
    STARBOND 650SF: Porcelain to precious metal alloy suitable for single units, short and long span bridges for metal ceramics, as well as implant over structures.
    STARBOND 780G: Porcelain to precious metal alloy suitable for a wide range of applications including: single units, short and long span bridges for metal ceramics and milled work and implant over structures.
    STARBOND 860G: Porcelain to precious metal alloy surface for Single surface intact inlays, crowns, small and long span bridges as well as crown and bridge frames for metal ceramics
    STARBOND 990G: Porcelain to precious metal alloy suitable for low stress situations only, single units with full porcelain coverage.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification document for several dental bonding alloys (StarBond SISG, S250, S75P, 650SF, 780G, 860G, 990G). The document details the FDA's substantial equivalence determination. However, it does not contain information about acceptance criteria, study designs, sample sizes, ground truth establishment, or multi-reader multi-case studies as requested.

    The document is a regulatory approval letter based on substantial equivalence to predicate devices, not a performance study report for a new device's efficacy or safety. Therefore, the requested information cannot be extracted from the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1