Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K013969
    Device Name
    MINIBLASTER
    Manufacturer
    Date Cleared
    2002-01-10

    (38 days)

    Product Code
    Regulation Number
    872.6080
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MINIBLASTER

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

    Miniblaster is an autoclavable clinical sandblaster for:

    • Sandblasting of metal surfaces prior to cementation of crown and inlays, bridges, . Maryland bridges.
    • Sandblasting to remove residual cement from crowns and bridged. .
    • Sandblasting of porcelain and resin surfaces prior to bonding and replaces use of . hydrofluoric acid for add-on repairs.
    • Sandblasting of orthodontic bands removes cement and enhances bonding. ●
    • Acrylic facings can be restored by sandblasting and using a direct metal adhesive. ●
    • Sandblasting of all surfaces to be bonded. .
    Device Description

    Miniblaster is an autoclavable clinical sandblaster

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental device called "MiniBlaster Clinical Sandblaster." It states that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies. These details are typically found in the 510(k) submission summary or other supporting documentation, which is not present here.

    Therefore, I cannot provide the requested table and study details based on the input text. The input only indicates the FDA's clearance of the device based on substantial equivalence, and lists its intended uses.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1