BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Inclusive® GL Titanium Abutment 6 mmH compatible with: BioHorizons® Tapered Internal 4.5 mm

    Reg #: 3011649314 · FEI: 3011649314 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    51
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    PRISMATIK DENTALCRAFT, INC.
    Registration Number
    3011649314
    FEI Number
    3011649314
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2144 Michelson Drive
    City
    Irvine
    State
    CA
    ZIP
    92612
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223496

    Owner / Operator

    Firm Name
    PRISMATIK DENTALCRAFT, INC.
    Operator Number
    10043585
    Address
    2144 Michelson Drive
    City
    Irvine
    State
    CA
    Postal Code
    92612
    Country
    US
    Correspondent
    Michelle Gallup

    Products

    Device Name Product Code
    Abutment, Implant, Dental, Endosseous NHA

    Proprietary Names

    Inclusive® GL Titanium Abutment 6 mmH compatible with: BioHorizons® Tapered Internal 4.5 mm Inclusive® GL Titanium Abutment 4.5 mmH compatible with: BioHorizons® Tapered Internal 3 mm Inclusive® Titanium Abutment Blank compatible with: MIS® C1 WP Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: MIS® C1 WP Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: BioHorizons® Tapered Internal 5.7 mm Inclusive® Multi-Unit Coping 4.5 mmH compatible with: BioHorizons® Tapered Internal Inclusive® GL Titanium Abutment 6 mmH compatible with: BioHorizons® Tapered Internal 3.5 mm Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: MIS® C1 NP Inclusive® Titanium Abutment Blank compatible with: MIS® C1 SP Inclusive® GL Titanium Abutment 4.5 mmH compatible with: MIS® C1 SP Inclusive® Multi-Unit Coping 8 mmH compatible with: MIS® Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: BioHorizons® Tapered Internal 3.5 mm Inclusive® GL Titanium Abutment 6 mmH compatible with: MIS® C1 SP Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Straumann® Bone Level SC 2.9 mm Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: BioHorizons® Tapered Internal 4.5 mm Inclusive® Titanium Abutment Blank compatible with: BioHorizons® Tapered Internal 4.5 mm Inclusive® GL Titanium Abutment 6 mmH compatible with: MIS® C1 WP Inclusive® Multi-Unit Coping Screw compatible with: MIS® Inclusive® Titanium Screw compatible with: BioHorizons® Tapered Internal Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: MIS® C1 SP Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: BioHorizons® Tapered Internal 4.5 mm Inclusive® Titanium Abutment Blank compatible with: Straumann® Bone Level SC 2.9 mm Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: BioHorizons® Tapered Internal 3 mm Inclusive® GL Titanium Abutment 6 mmH compatible with: MIS® C1 NP Inclusive® GL Titanium Abutment 6 mmH compatible with: BioHorizons® Tapered Internal 5.7 mm Inclusive® Titanium Screw compatible with: MIS® SP Inclusive® Titanium Screw compatible with: MIS® NP Inclusive® Titanium Abutment Blank compatible with: MIS® C1 NP Inclusive® Titanium Abutment Blank compatible with: BioHorizons® Tapered Internal 3 mm Inclusive® Titanium Screw compatible with: MIS® WP Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: MIS® C1 NP Inclusive® GL Titanium Abutment 6 mmH compatible with: Straumann® Bone Level SC 2.9 mm Inclusive® Titanium Screw compatible with: Straumann® Bone Level SC 2.9 mm Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: BioHorizons® Tapered Internal 3.5 mm Inclusive® Multi-Unit Coping 8 mmH compatible with: BioHorizons® Tapered Internal Inclusive® GL Titanium Abutment 4.5 mmH compatible with: MIS® C1 WP Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: BioHorizons® Tapered Internal 3 mm Inclusive® GL Titanium Abutment 6 mmH compatible with: BioHorizons® Tapered Internal 3 mm Inclusive® GL Titanium Abutment 4.5 mmH compatible with: BioHorizons® Tapered Internal 4.5 mm Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: BioHorizons® Tapered Internal 5.7 mm Inclusive® Titanium Abutment Blank compatible with: BioHorizons® Tapered Internal 5.7 mm Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: MIS® C1 SP Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: Straumann® Bone Level SC 2.9 mm Inclusive® GL Titanium Abutment 4.5 mmH compatible with: MIS® C1 NP Inclusive® GL Titanium Abutment 4.5 mmH compatible with: BioHorizons® Tapered Internal 5.7 mm Inclusive® GL Titanium Abutment 4.5 mmH compatible with: Straumann® Bone Level SC 2.9 mm Inclusive® Titanium Abutment Blank compatible with: BioHorizons® Tapered Internal 3.5 mm Inclusive® Multi-Unit Coping Screw compatible with: BioHorizons® Tapered Internal Inclusive® GL Titanium Abutment 4.5 mmH compatible with: BioHorizons® Tapered Internal 3.5 mm Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: MIS® C1 WP Inclusive® Multi-Unit Coping 4.5 mmH compatible with: MIS®

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198