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510(k) Data Aggregation

    K Number
    K260370

    Validate with FDA (Live)

    Date Cleared
    2026-03-30

    (53 days)

    Product Code
    Regulation Number
    872.6660
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K212765

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

    HT-plus, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML, 3D-Pro-ML, HTP-plus, STP, STP-C, STP-ML, SHTP, SHTP-C, SHTP-ML, 3DP-Pro-ML are indicated for the treatment of partial or total loss of anatomical crown in the anterior and posterior tooth regions, from single crown to up to 14-unit teeth, i.e. the manufacturing of

    • anatomically reduced and fully anatomical (monolithic) crowns in the anterior and posterior tooth range (e.g. single-tooth crowns, inlays, onlays, veneers);
    • anatomically reduced and fully anatomical (monolithic) bridges (up to 14 units) in the anterior and posterior tooth range.

    UT, UT-C, UT-ML, UTP, UTP-C, UTP-ML are indicated for the treatment of partial or total loss of anatomical crown in the anterior and posterior tooth regions, from single crown to up to 3-unit teeth, i.e. the manufacturing of

    • anatomically reduced and fully anatomical (monolithic) crowns in the anterior and posterior tooth range (e.g. single-tooth crowns, inlays, onlays, veneers);
    • anatomically reduced and fully anatomical (monolithic) bridges (up to 3 units) in the anterior and posterior tooth range.
    Device Description

    Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is composed of yttria-stabilized zirconia. The yttria-stabilized zirconia has a long history of safe use in dentistry.

    Bloomden Dental Zirconia Blank is white, and it is composed of ZrO₂ + HfO₂ + Y₂O₃ and additional other oxides. Bloomden Dental Zirconia Pre-Shaded Blank is color (containing 20 available Vita shades), and it contains not only the ingredients same as the white zirconia blank but also very small amount of additional inorganic pigments (Fe₂O₃, Er₂O₃, MnO/Co₃O₄). The inorganic pigments generate the color on the restorations, after sintering in dental labs, matching natural color of patient's teeth. And there are two color representations (i.e. monolayer and multilayer) for the color zirconia blank.

    The proposed device is provided in various translucency. It also offers various shapes and dimensions suitable for different milling systems.

    The proposed device is processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays, based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method.

    The performance of the proposed device conforms to ISO 6872:2024 Dentistry - Ceramic Materials.

    The proposed device is a single-use device, and provided non-sterile. The shelf life is 5 years.

    AI/ML Overview

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