BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Inclusive Titanium Abutment 6 mmH compatible with: Biomet 3i™ Certain 3.4 mm

    Reg #: 3011649314 · FEI: 3011649314 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    164
    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
    K142115

    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 Titanium Abutment 6 mmH compatible with: Biomet 3i™ Certain 3.4 mm Inclusive Implant Analog compatible with: Zimmer Dental Screw-Vent 3.5 mm Inclusive GL Titanium Abutment 4.5 mmH compatible with: Nobel Biocare NobelReplace NP Inclusive 17 degree MU Abut 2 mmH compatible with: Biomet 3i Certain 3.4 (pack) Inclusive Titanium Abutment Blank compatible with: Nobel Biocare NobelReplace RP Inclusive Zirconia Abutment Screw compatible with: Zimmer Dental Screw-Vent 3.5/4.5/5.7 mm Inclusive 15 degree Titanium Esthetic Abutment, Anterior, compatible with: Biomet 3i Certain 3.4 mm Inclusive Titanium Abutment 6 mmH compatible with: Nobel Biocare NobelReplace 6 Inclusive GL Titanium Abutment 6 mmH compatible with: Nobel Biocare NobelReplace 6 Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Zimmer Dental Screw-Vent 3.5 mm Inclusive Titanium Screw compatible with: Zimmer Dental Screw-Vent 3.5/4.5/5.7 mm Titanium Screw (5-pack) compatible with: Biomet 3i™ Certain 3.4/4.1/5/6 mm Inclusive Titanium Abutment Blank compatible with: Biomet 3i™ Certain 6 mm Inclusive Titanium Abutment 3 mmH compatible with: Biomet 3i Certain 4.1 mm Inclusive Titanium Abutment 6 mmH compatible with: Biomet 3i™ Certain 4.1 mm Inclusive GL Titanium Abutment 6 mmH compatible with: Biomet 3i Certain 5 mm Inclusive Laboratory Screw (5-pack) compatible with: Zimmer Dental Screw-Vent 3.5/4.5/5.7 mm Inclusive Titanium Esthetic Abutment, Anterior, compatible with: Nobel Biocare NobelReplace RP Inclusive Laboratory Screw compatible with: Nobel Biocare NobelReplace NP Inclusive Titanium Esthetic Abutment, Anterior, compatible with: Biomet 3i Certain 5 mm Titanium Wide Collar Screw for Biomet 3i Certain Inclusive Laboratory Screw (5-pack) compatible with: Biomet 3i™ Certain 3.4/4.1/5/6 mm Inclusive Titanium Abutment Blank compatible with: Biomet 3i Certain 6 mm Inclusive Titanium Screw (5-pack) compatible with: Nobel Biocare NobelReplace NP Inclusive Titanium Abutment 3 mmH compatible with: Biomet 3i Certain 6 mm Inclusive Titanium Abutment Blank compatible with: Biomet 3i Certain 3.4 mm Inclusive Titanium Abutment 3 mmH compatible with: Zimmer Dental Screw-Vent 5.7 mm Inclusive Zirconia Abutment Screw compatible with: Biomet 3i Certain 3.4/4.1/5/6 mm Inclusive Titanium Esthetic Abutment, Anterior, compatible with: Biomet 3i™ Certain 5 mm Inclusive Titanium Abutment 6 mmH compatible with: Zimmer Dental Screw-Vent 3.5 mm Inclusive Titanium Abutment Blank compatible with: Biomet 3i™ Certain 5 mm Inclusive Titanium Abutment 6 mmH compatible with: Biomet 3i Certain 3.4 mm Inclusive 15 degree Titanium Esthetic Abutment, Anterior, compatible with: Nobel Biocare NobelReplace NP Inclusive Titanium Esthetic Abutment, Anterior, compatible with: Nobel Biocare NobelReplace WP Titanium Screw (5-pack) compatible with: Zimmer Dental Screw-Vent 3.5/4.5/5.7 mm Inclusive Zirconia Abutment Screw compatible with: Nobel Biocare NobelReplace RP/WP/6 Inclusive GL Titanium Abutment 6 mmH compatible with: Nobel Biocare NobelReplace WP Inclusive 15 degree Titanium Esthetic Abutment, Anterior, compatible with: Nobel Biocare NobelReplace WP Inclusive Titanium Abutment Blank compatible with: Zimmer Dental Screw-Vent 4.5 mm Inclusive Titanium Abutment Blank compatible with: Biomet 3i™ Certain 4.1 mm Inclusive Titanium Abutment 6 mmH compatible with: Biomet 3i Certain 6 mm Inclusive GL Titanium Abutment 4.5 mmH compatible with: Biomet 3i Certain 6 mm Inclusive Titanium Abutment 4.5 mmH compatible with: Nobel Biocare NobelReplace RP Inclusive GL Titanium Abutment 4.5 mmH compatible with: Nobel Biocare NobelReplace 6 Inclusive Laboratory Screw compatible with: Biomet 3i™ Certain 3.4/4.1/5/6 mm Inclusive GL Titanium Abutment 6 mmH compatible with: Biomet 3i Certain 6 mm Inclusive GL Titanium Abutment 4.5 mmH compatible with: Zimmer Dental Screw-Vent 5.7 mm Custom Impression Coping Screw for Zimmer Screw-Vent Inclusive Titanium Esthetic Abutment, Anterior, compatible with: Biomet 3i Certain 4.1 mm Inclusive Titanium Abutment 4.5 mmH compatible with: Zimmer Dental Screw-Vent 4.5 mm Inclusive GL Titanium Abutment 4.5 mmH compatible with: Zimmer Dental Screw-Vent 3.5 mm Inclusive Titanium Abutment 3 mmH compatible with: Biomet 3i Certain 5 mm Titanium Screw for Zimmer Screw-Vent Inclusive 15 degree Titanium Esthetic Abutment, Anterior, compatible with: Nobel Biocare NobelReplace RP Inclusive Titanium Abutment Blank compatible with: Nobel Biocare NobelReplace WP Inclusive Titanium Abutment 4.5 mmH compatible with: Biomet 3i™ Certain 6 mm Inclusive Titanium Abutment Blank compatible with: Biomet 3i Certain 5 mm Inclusive Titanium Abutment 6 mmH compatible with: Zimmer Dental Screw-Vent 5.7 mm Inclusive Titanium Abutment 4.5 mmH compatible with: Zimmer Dental Screw-Vent 3.5 mm Inclusive Zirconia Abutment Screw compatible with: Nobel Biocare NobelReplace NP Inclusive Titanium Screw compatible with: Nobel Biocare NobelReplace RP/WP/6 Inclusive Titanium Esthetic Abutment, Posterior, compatible with: Nobel Biocare NobelReplace 6 Inclusive Titanium Abutment 3 mmH compatible with: Nobel Biocare NobelReplace 6 Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Biomet 3i Certain 4.1 mm Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Biomet 3i Certain 6 mm Inclusive 15 Degree Titanium Esthetic Abutment, Anterior, compatible with: Biomet 3i™ Certain 5 mm Inclusive Laboratory Screw (5-pack) compatible with: Nobel Biocare NobelReplace NP Inclusive Implant Analog compatible with: Zimmer Dental Screw-Vent 4.5 mm Inclusive Titanium Abutment Blank compatible with: Zimmer Dental Screw-Vent 5.7 mm Inclusive Titanium Abutment 3 mmH compatible with: Biomet 3i™ Certain 3.4 mm Inclusive Titanium Abutment 4.5 mmH compatible with: Biomet 3i Certain 3.4 mm Inclusive Titanium Screw (5-pack) compatible with: Biomet 3i Certain 3.4/4.1/5/6 mm Inclusive Titanium Screw compatible with: Biomet 3i Certain 3.4/4.1/5/6 mm Inclusive GL Titanium Abutment 4.5 mmH compatible with: Nobel Biocare NobelReplace RP Inclusive Titanium Abutment 3 mmH compatible with: Biomet 3i™ Certain 4.1 mm Inclusive Titanium Screw (5-pack) compatible with: Zimmer Dental Screw-Vent 3.5/4.5/5.7 mm Inclusive Titanium Abutment 6 mmH compatible with: Biomet 3i™ Certain 6 mm Inclusive Titanium Abutment 6 mmH compatible with: Nobel Biocare NobelReplace NP Inclusive Laboratory Screw compatible with: Zimmer Dental Screw-Vent 3.5/4.5/5.7 mm Inclusive Titanium Abutment Blank compatible with: Biomet 3i Certain 4.1 mm Inclusive Titanium Abutment 4.5 mmH compatible with: Biomet 3i™ Certain 3.4 mm Inclusive Titanium Abutment 3 mmH compatible with: Zimmer Dental Screw-Vent 3.5 mm Inclusive Titanium Abutment 6 mmH compatible with: Biomet 3i™ Certain 5 mm Titanium Screw (5-pack) compatible with: Biomet 3i Certain 3.4/4.1/5/6 mm Inclusive Titanium Esthetic Abutment, Posterior, compatible with: Biomet 3i™ Certain 6 mm Inclusive Titanium Esthetic Abutment, Posterior, compatible with: Biomet 3i Certain 5 mm Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Zimmer Dental Screw-Vent 4.5 mm Inclusive 15 Degree Titanium Esthetic Abutment, Posterior, compatible with: Biomet 3i™ Certain 4.1 mm Inclusive GL Titanium Abutment 4.5 mmH compatible with: Biomet 3i Certain 4.1 mm Inclusive GL Titanium Abutment 4.5 mmH compatible with: Nobel Biocare NobelReplace WP Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Zimmer Dental Screw-Vent 5.7 mm Inclusive Titanium Abutment 6 mmH compatible with: Biomet 3i Certain 5 mm Inclusive Titanium Abutment 6 mmH compatible with: Zimmer Dental Screw-Vent 4.5 mm Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Biomet 3i Certain 5 mm Inclusive 15 degree Titanium Esthetic Abutment, Posterior, compatible with: Biomet 3i Certain 4.1 mm Inclusive Titanium Abutment Blank compatible with: Nobel Biocare NobelReplace 6 Inclusive 15 degree Titanium Esthetic Abutment, Posterior, compatible with: Biomet 3i Certain 5 mm Inclusive GL Titanium Abutment 6 mmH compatible with: Biomet 3i Certain 4.1 mm Inclusive Titanium Esthetic Abutment, Posterior, compatible with: Biomet 3i Certain 4.1 mm Inclusive Titanium Abutment 4.5 mmH compatible with: Biomet 3i Certain 5 mm Inclusive Titanium Esthetic Abutment, Anterior, compatible with: Nobel Biocare NobelReplace NP Inclusive Titanium Abutment 4.5 mmH compatible with: Nobel Biocare NobelReplace NP Inclusive GL Titanium Abutment 6 mmH compatible with: Zimmer Dental Screw-Vent 4.5 mm Titanium Screw compatible with: Biomet 3i™ Certain 3.4/4.1/5/6 mm Inclusive Implant Analog compatible with: Zimmer Dental Screw-Vent 5.7 mm Inclusive Titanium Abutment 4.5 mmH compatible with: Nobel Biocare NobelReplace 6 Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Nobel Biocare NobelReplace WP Inclusive Titanium Abutment 6 mmH compatible with: Biomet 3i Certain 4.1 mm Inclusive 15 degree Titanium Esthetic Abut, Posterior, compatible with: Nobel Biocare NobelReplace RP Inclusive GL Titanium Abutment 6 mmH compatible with: Biomet 3i Certain 3.4 mm Titanium Screw compatible with: Nobel Biocare NobelReplace NP Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Nobel Biocare NobelReplace RP Inclusive Titanium Abutment 4.5 mmH compatible with: Biomet 3i Certain 4.1 mm Inclusive Titanium Abutment 4.5 mmH compatible with: Nobel Biocare NobelReplace WP Inclusive Laboratory Screw compatible with: Nobel Biocare NobelReplace RP/WP/6 Inclusive Titanium Abutment 3 mmH compatible with: Nobel Biocare NobelReplace NP Inclusive Titanium Abutment 3 mmH compatible with: Biomet 3i Certain 3.4 mm Titanium Screw (5-pack) compatible with: Nobel Biocare NobelReplace NP Inclusive Titanium Abutment Blank compatible with: Zimmer Dental Screw-Vent 3.5 mm Inclusive Titanium Esthetic Abutment, Posterior, compatible with: Biomet 3i Certain 6 mm Inclusive Titanium Abutment 3 mmH compatible with: Zimmer Dental Screw-Vent 4.5 mm Inclusive 15 degree Titanium Esthetic Abut, Posterior, compatible with: Nobel Biocare NobelReplace WP Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Nobel Biocare NobelReplace 6 Inclusive Titanium Screw (5-pack) compatible with: Nobel Biocare NobelReplace RP/WP/6 Inclusive Laboratory Screw (5-pack) compatible with: Nobel Biocare NobelReplace RP/WP/6 Inclusive 17 degree MU Abut 2 mmH compatible with: Biomet 3i Certain 3.4 (pack) Inclusive 15 degree Titanium Esthetic Abutment, Anterior, compatible with: Biomet 3i Certain 5 mm Titanium Screw compatible with: Biomet 3i Certain 3.4/4.1/5/6 mm Inclusive Laboratory Screw (5-pack) compatible with: Biomet 3i Certain 3.4/4.1/5/6 mm Inclusive Titanium Esthetic Abutment, Anterior, compatible with: Biomet 3i™ Certain 4.1 mm Inclusive 15 Degree Titanium Esthetic Abutment, Anterior, compatible with: Biomet 3i™ Certain 4.1 mm Inclusive GL Titanium Abutment 4.5 mmH compatible with: Zimmer Dental Screw-Vent 4.5 mm Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Biomet 3i Certain 3.4 mm Inclusive Titanium Abutment 3 mmH compatible with: Nobel Biocare NobelReplace RP Inclusive GL Titanium Abutment 6 mmH compatible with: Zimmer Dental Screw-Vent 5.7 mm Inclusive Titanium Esthetic Abutment, Posterior, compatible with: Biomet 3i™ Certain 4.1 mm Inclusive Titanium Abutment 4.5 mmH compatible with: Zimmer Dental Screw-Vent 5.7 mm Inclusive Laboratory Screw compatible with: Biomet 3i Certain 3.4/4.1/5/6 mm Inclusive GL Titanium Abutment 4.5 mmH compatible with: Biomet 3i Certain 3.4mm Inclusive Titanium Abutment 4.5 mmH compatible with: Biomet 3i™ Certain 5 mm Inclusive GL Titanium Abutment 4.5 mmH compatible with: Biomet 3i Certain 5 mm Inclusive GL Titanium Abutment 6 mmH compatible with: Nobel Biocare NobelReplace NP Inclusive Titanium Esthetic Abutment, Anterior, compatible with: Biomet 3i™ Certain 3.4 mm Titanium Screw (5-pack) compatible with: Nobel Biocare NobelReplace RP/WP/6 Inclusive Titanium Abutment Blank compatible with: Biomet 3i™ Certain 3.4 mm Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Nobel Biocare NobelReplace NP Inclusive Titanium Abutment 4.5 mmH compatible with: Biomet 3i Certain 6 mm Inclusive Titanium Esthetic Abutment, Posterior, compatible with: Biomet 3i™ Certain 5 mm Inclusive Titanium Esthetic Abutment, Posterior, compatible with: Nobel Biocare NobelReplace RP Inclusive Titanium Abutment 3 mmH compatible with: Biomet 3i™ Certain 5 mm Inclusive GL Titanium Abutment 6 mmH compatible with: Nobel Biocare NobelReplace RP Inclusive 15 degree Titanium Esthetic Abutment, Anterior, compatible with: Biomet 3i Certain 4.1 mm Inclusive Titanium Abutment 4.5 mmH compatible with: Biomet 3i™ Certain 4.1 mm Inclusive 15 Degree Titanium Esthetic Abutment, Posterior, compatible with: Biomet 3i™ Certain 5 mm Inclusive Titanium Abutment 3 mmH compatible with: Biomet 3i™ Certain 6 mm Inclusive Titanium Abutment 6 mmH compatible with: Nobel Biocare NobelReplace WP Inclusive Titanium Abutment 3 mmH compatible with: Nobel Biocare NobelReplace WP Inclusive Titanium Esthetic Abutment, Posterior, compatible with: Nobel Biocare NobelReplace WP Inclusive GL Titanium Abutment 6 mmH compatible with: Zimmer Dental Screw-Vent 3.5 mm Inclusive 15 Degree Titanium Esthetic Abutment, Anterior, compatible with: Biomet 3i™ Certain 3.4 mm Titanium Screw compatible with: Nobel Biocare NobelReplace RP/WP/6 Inclusive Titanium Abutment Blank compatible with: Nobel Biocare NobelReplace NP Inclusive Titanium Esthetic Abutment, Anterior, compatible with: Biomet 3i Certain 3.4 mm Inclusive Titanium Abutment 6 mmH compatible with: Nobel Biocare NobelReplace RP

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198