BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Inclusive GL Titanium Abutment 6 mmH compatible with: Nobel Biocare NobelActive RP

    Reg #: 3011649314 · FEI: 3011649314 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    84
    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
    K142118

    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: Nobel Biocare NobelActive RP Inclusive 15 degree Titanium Esthetic Abutment, Anterior, compatible with: Straumann Bone Level NC Titanium Screw (5-pack) compatible with: Nobel Biocare Branemark System RP Inc Titanium Abut 4.5 mmH, NE, compatible with: Nobel Biocare Branemark System RP Titanium Screw (5-pack) compatible with: Nobel Biocare NobelActive NP Inclusive Titanium Abutment 4.5 mmH compatible with: Straumann Bone Level RC Inclusive Laboratory Screw compatible with: Nobel Biocare Branemark System RP Inclusive Titanium Screw compatible with: Nobel Biocare Branemark System RP Inclusive GL Titanium Abutment 6 mmH compatible with: Straumann Bone Level NC Inclusive 15 degree Titanium Esthetic Abutment, Posterior, compatible with: Straumann Bone Level RC Inclusive Titanium Abutment 6 mmH compatible with: Straumann Bone Level NC Inclusive Titanium Screw compatible with: Straumann Bone Level NC Titanium Screw (5-pack) compatible with: Nobel Biocare NobelActive RP Inclusive GL Titanium Abutment 4.5 mmH compatible with: Nobel Biocare NobelActive NP Inclusive Laboratory Screw (5-pack) compatible with: Straumann Bone Level NC Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Straumann Bone Level RC Titanium Abutment 4.5 mmH compatible with: Nobel Biocare Branemark System RP Inclusive Titanium Abutment 4.5 mmH compatible with: Straumann Tissue Level WN synOcta Titanium Screw (5-pack) compatible with: Straumann Bone Level RC Inclusive Titanium Abutment 6 mmH compatible with: Nobel Biocare NobelActive NP Titanium Screw (5-pack) compatible with: Straumann Bone Level NC Inclusive Titanium Esthetic Abutment, Posterior, compatible with: Straumann Bone Level RC Titanium Screw compatible with: Nobel Biocare Branemark System RP Inclusive Titanium Abutment Blank compatible with: Nobel Biocare NobelActive RP Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Nobel Biocare NobelActive NP Titanium Screw compatible with: Nobel Biocare NobelActive NP Inclusive Titanium Esthetic Abutment, Anterior, compatible with: Nobel Biocare Branemark System RP Inclusive Laboratory Screw compatible with: Nobel Biocare NobelActive RP Inclusive Titanium Abutment 3 mmH compatible with: Nobel Biocare Branemark System RP Inclusive Titanium Abutment 6 mmH compatible with: Straumann Tissue Level RN synOcta Inclusive Titanium Screw (5-pack) compatible with: Straumann Bone Level NC Inclusive Titanium Esthetic Abutment, Posterior, compatible with: Nobel Biocare NobelActive RP Inclusive Titanium Abutment 6 mmH compatible with: Nobel Biocare NobelActive RP Inclusive Laboratory Screw (5-pack) compatible with: Nobel Biocare Branemark System RP Inclusive Titanium Esthetic Abutment, Anterior, compatible with: Straumann Bone Level NC Inclusive Laboratory Screw (5-pack) compatible with: Nobel Biocare NobelActive RP Inclusive GL Titanium Abutment 6 mmH compatible with: Nobel Biocare Branemark System RP Inclusive Titanium Screw (5-pack) compatible with: Nobel Biocare NobelActive NP Inclusive Titanium Abutment Blank compatible with: Nobel Biocare Branemark System RP Inclusive GL Titanium Abutment 6 mmH compatible with: Straumann Bone Level RC Inclusive Laboratory Screw compatible with: Straumann Bone Level NC Inclusive Titanium Abutment 3 mmH compatible with: Straumann Bone Level NC Inclusive Titanium Abutment Blank compatible with: Nobel Biocare NobelActive NP Inclusive 15 degree Titanium Esthetic Abutment, Anterior, compatible with: Nobel Biocare NobelActive RP Inclusive Titanium Screw (5-pack) compatible with: Nobel Biocare Branemark System RP Inclusive Titanium Abutment 4.5 mmH, non-engaging compatible with: Straumann Tissue Level WN synOcta Inclusive Titanium Esthetic Abutment, Posterior, compatible with: Nobel Biocare Branemark System RP Inclusive 15 degree Titanium Esthetic Abutment, Posterior, compatible with: Nobel Biocare NobelActive RP Inclusive GL Titanium Abutment 6 mmH compatible with: Nobel Biocare NobelActive NP Inclusive Titanium Abutment 6 mmH compatible with: Straumann Bone Level RC Inclusive Titanium Esthetic Abutment, Anterior, compatible with: Nobel Biocare NobelActive RP Inclusive GL Titanium Abutment 4.5 mmH compatible with: Straumann Bone Level RC Inclusive Titanium Abutment 4.5 mmH compatible with: Nobel Biocare NobelActive NP Inclusive GL Titanium Abutment 4.5 mmH compatible with: Nobel Biocare NobelActive RP Inclusive Titanium Abutment 3 mmH compatible with: Nobel Biocare NobelActive NP Inclusive Laboratory Screw compatible with: Straumann Bone Level RC Inclusive Titanium Abutment Blank compatible with: Straumann Bone Level RC Inclusive Titanium Esthetic Abutment, Anterior, compatible with: Straumann Bone Level RC Inclusive GL Titanium Abutment 4.5 mmH compatible with: Nobel Biocare Branemark System RP Inclusive Titanium Abutment Blank compatible with: Straumann Bone Level NC Inclusive Titanium Screw compatible with: Nobel Biocare NobelActive RP Inclusive Titanium Abutment 4.5 mmH, non-engaging compatible with: Nobel Biocare Branemark System RP Inclusive Titanium Abutment 4.5 mmH compatible with: Straumann Tissue Level RN synOcta Inclusive Laboratory Screw compatible with: Nobel Biocare NobelActive NP Inclusive Titanium Abutment 4.5 mmH compatible with: Nobel Biocare NobelActive RP Inclusive Titanium Screw (5-pack) compatible with: Straumann Bone Level RC Inclusive Titanium Abutment 6 mmH compatible with: Nobel Biocare Branemark System RP Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Nobel Biocare NobelActive RP Inclusive Laboratory Screw (5-pack) compatible with: Nobel Biocare NobelActive NP Inclusive 15 degree Titanium Esthetic Abutment, Anterior, compatible with: Nobel Biocare NobelActive NP Inclusive Titanium Abutment 3 mmH compatible with: Nobel Biocare NobelActive RP Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Straumann Bone Level NC Inclusive Titanium Abutment 6 mmH compatible with: Straumann Tissue Level WN synOcta Inclusive Titanium Abutment 4.5 mmH compatible with: Straumann Bone Level NC Inclusive GL Titanium Abutment 4.5 mmH compatible with: Straumann Bone Level NC Inclusive 15 degree Titanium Esthetic Abutment, Anterior, compatible with: Straumann Bone Level RC Titanium Screw compatible with: Straumann Bone Level NC Inclusive Titanium Esthetic Abutment, Anterior, compatible with: Nobel Biocare NobelActive NP Titanium Screw compatible with: Nobel Biocare NobelActive RP Inclusive Titanium Abutment 3 mmH compatible with: Straumann Bone Level RC Inclusive Titanium Screw (5-pack) compatible with: Nobel Biocare NobelActive RP Titanium Screw compatible with: Straumann Bone Level RC Inclusive Titanium Abutment 4.5 mmH, non-engaging compatible with: Straumann Tissue Level RN synOcta Inclusive Laboratory Screw (5-pack) compatible with: Straumann Bone Level RC

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198