BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Esthetic Abutment, Anterior, 15 Degree Angle for Astra 4.5/5

    Reg #: 3011649314 · FEI: 3011649314 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    63
    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
    K100993

    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

    Esthetic Abutment, Anterior, 15 Degree Angle for Astra 4.5/5 Inclusive Titanium Abut Blank compatible with: Dentsply Implants Astra Tech Implant System 3.5/4 6 mm Abutment for Astra 3 Inclusive 15 Degree Ti Est Abut, Anterior, compatible with: Dentsply Implants Astra Tech Implant System 3 Titanium Screw for Astra 4.5/5 Inclusive Ti Est Abut, Anterior, compatible with: Dentsply Implants Astra Tech Implant System 3.5/4 6 mm Abutment for Astra 4.5/5 Inclusive Titanium Abut 6 mmH compatible with: Dentsply Implants Astra Tech Implant System 4.5/5 Titanium Screw for Astra 3.5/4 Esthetic Abutment, Anterior, 15 Degree Angle for Astra 3 4.5 mm Abutment Engaging for Astra 3.5/4 Inclusive Titanium Abut 3 mmH compatible with: Dentsply Implants Astra Tech Implant System 3 Inclusive Titanium Abut 6 mmH compatible with: Dentsply Implants Astra Tech Implant System 3 Esthetic Abutment, Posterior, 15 Degree Angle for Astra 4.5/5 Inclusive 15 Degree Ti Est Abut, Post, compatible with: Dentsply Implants Astra Tech Implant System 3.5/4 Inclusive Ti Abut 4.5 mmH, NE, compatible with: Dentsply Implants Astra Tech Implant System 3.5/4 Inclusive Titanium Abut 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 3 Titanium Screw (5-pack) compatible with: Dentsply Implants Astra Tech Implant System 4.5/5 Titanium Screw for Astra 3 6 mm Abutment for Astra 3.5/4 Esthetic Abutment, Posterior, 15 Degree Angle for Astra 3.5/4 Titanium Screw compatible with: Dentsply Implants Astra Tech Implant System 3 Titanium Screw (5-pack) compatible with: Dentsply Implants Astra Tech Implant System 3.5/4 Inclusive Titanium Abut 3 mmH compatible with: Dentsply Implants Astra Tech Implant System 3.5/4 Inclusive Ti Est Abut, Posterior, compatible with: Dentsply Implants Astra Tech Implant System 4.5/5 Inclusive Titanium Abut 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 3.5/4 Esthetic Abutment, Anterior, Straight for Astra 4.5/5 Inclusive 15 Degree Ti Est Abut, Post, compatible with: Dentsply Implants Astra Tech Implant System 4.5/5 Esthetic Abutment, Posterior, Straight for Astra 4.5/5 4.5 mm Abutment Non-Engaging for Astra 4.5/5 Inclusive Ti Abut 4.5 mmH, NE, compatible with: Dentsply Implants Astra Tech Implant System 4.5/5 Inclusive Titanium Abut 6 mmH compatible with: Dentsply Implants Astra Tech Implant System 3.5/4 Inclusive Ti Est Abut, Posterior, compatible with: Dentsply Implants Astra Tech Implant System 3.5/4 Titanium Screw (5-pack) compatible with: Dentsply Implants Astra Tech Implant System 3 Inclusive 15 Degree Ti Est Abut, Ant, compatible with: Dentsply Implants Astra Tech Implant System 4.5/5 Inclusive Titanium Abut 3 mmH compatible with: Dentsply Implants Astra Tech Implant System 4.5/5 Titanium Screw for Astra 3.5/4 5/pk Inclusive Titanium Abut Blank compatible with: Dentsply Implants Astra Tech Implant System 3 Inclusive Titanium Abut Blank compatible with: Dentsply Implants Astra Tech Implant System 4.5/5 Esthetic Abutment, Anterior, Straight for Astra 3.5/4 3 mm Abutment for Astra 3.5/4 Inclusive 15 Degree Ti Est Abut, Ant, compatible with: Dentsply Implants Astra Tech Implant System 3.5/4 Inclusive Titanium Abut 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 4.5/5 Titanium Screw for Astra 3 5/pk Esthetic Abutment, Anterior, Straight for Astra 3 Titanium Screw compatible with: Dentsply Implants Astra Tech Implant System 4.5/5 Titanium Screw compatible with: Dentsply Implants Astra Tech Implant System 3.5/4 3 mm Abutment for Astra 3 4.5 mm Abutment Non-Engaging for Astra 3.5/4 Titanium Screw for Astra 4.5/5 5/pk Inclusive Ti Est Abut, Anterior, compatible with: Dentsply Implants Astra Tech Implant System 3 Esthetic Abutment, Posterior, Straight for Astra 3.5/4 Inclusive Ti Est Abut, Anterior, compatible with: Dentsply Implants Astra Tech Implant System 4.5/5 4.5 mm Abutment Engaging for Astra 4.5/5 4.5 mm Abutment Engaging for Astra 3 3 mm Abutment for Astra 4.5/5 Esthetic Abutment, Anterior, 15 Degree Angle for Astra 3.5/4 Inclusive GL Titanium Abutment 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 3 Inclusive GL Titanium Abutment 6 mmH compatible with: Dentsply Implants Astra Tech Implant System 4.5/5 Inclusive GL Titanium Abutment 6 mmH compatible with: Dentsply Implants Astra Tech Implant System 3 Inclusive GL Titanium Abutment 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 3.5/4 Inclusive GL Titanium Abutment 6 mmH compatible with: Dentsply Implants Astra Tech Implant System 3.5/4 Inclusive GL Titanium Abutment 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 4.5/5

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198