BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Inclusive Tapered Implant UCLA Gold Abutment 3 mmP

    Reg #: 3011649314 · FEI: 3011649314 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    29
    Establishment Types
    2
    Classifications
    2

    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
    K153099

    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
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    Inclusive Tapered Implant UCLA Gold Abutment 3 mmP Inclusive Tapered Implant UCLA Plastic Abutment, Non-Engaging, 3 mmP Inclusive Tapered Implant UCLA Plastic Abutment 3 mmP Inclusive Tapered Implant GL Titanium Abutment 3 mmP x 4.5 mmH Inclusive Tapered Implant 3.2mmD x 10 mmL x 3 mmP Inclusive Tapered Implant Multi-Unit Abutment 3 mmP x 2.5 mmH Inclusive Tapered Implant Healing Abutment 3 mmP x 3.2 mmD x 5 mmH Inclusive Tapered Implant Healing Abutment 3 mmP x 3.7 mmD x 3 mmH Inclusive Tapered Implant Titanium Esthetic Abutment, Anterior, 3 mmP x 1.5 mmH Inclusive Tapered Implant Titanium Screw 3 mmP (5-pack) Inclusive Tapered Implant Healing Abutment 3 mmP x 3.7 mmD x 5 mmH Inclusive Tapered Implant 3.2mmD x 8 mmL x 3 mmP Inclusive Tapered Implant Healing Abutment 3 mmP x 3.2 mmD x 7 mmH Inclusive Tapered Implant Titanium Esthetic Abutment, Anterior, 3 mmP x 2.3 mmH Inclusive Tapered Implant Healing Abutment 3 mmP x 3.7 mmD x 7 mmH Inclusive Tapered Implant Titanium Abutment 3 mmP x 4.5 mmH Inclusive Tapered Implant 15 degree Titanium Esthetic Abutment, Anterior, 3 mmP x 1.5 mmH Inclusive Tapered Implant Multi-Unit Abutment 3 mmP x 3.5 mmH Inclusive Tapered Implant 15 degree Titanium Esthetic Abutment, Anterior, 3 mmP x 2.3 mmH Inclusive Tapered Implant 3.2mmD x 11.5 mmL x 3 mmP Inclusive Tapered Implant Temporary Abutment 3 mmP Inclusive Tapered Implant Titanium Screw 3 mmP Inclusive Tapered Implant Temporary Abutment, Non-Engaging, 3 mmP Inclusive Tapered Implant 3.2mmD x 16 mmL x 3 mmP Inclusive Tapered Implant Multi-Unit Abutment 3 mmP x 1.5 mmH Inclusive Tapered Implant Healing Abutment 3 mmP x 3.2 mmD x 3 mmH Inclusive Tapered Implant Titanium Abutment 3 mmP x 6 mmH Inclusive Tapered Implant 3.2mmD x 13 mmL x 3 mmP Inclusive Tapered Implant GL Titanium Abutment 3 mmP x 6 mmH

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device