BEUDAMED
    FDA Registration Active 🇺🇸 United States

    3mm Abutment 4.5mm x 6mm

    Reg #: 3011649314 · FEI: 3011649314 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    96
    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
    K953235

    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
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    3mm Abutment 4.5mm x 6mm Temporary Abutment 4.5mm Engaging Cover Screw 4.5 Lance Drill Closed-Tray Transfer 4.5 x 4.5 x 8 Scanning Abutment 4.5 Posterior Pilot Drill 2.3/2 Long 3mm Abutment 4.5mm x 3mm Surgical Drill 2.8/2.3 Short Surgical Dril 4.9/4.4 Short Multi-Unit Abutment Analog UCLA Gold Abutment 3.5 Platform Engaging 4.5 Anterior Straight Esthetic Abutment Handpiece Implant Driver (long) Implant Driver (long) 3.5 Posterior Angled Esthetic Abutment Surgical Bone Drill 2.8/2.3Long UCLA Plastic 3.5 Platform (non-engaging) UCLA Gold Abutment 4.5 Platform Engaging Multi-Unit Temporary Abutment 3.5 Open-Tray Impression Screw 4.5 Anterior Angled Esthetic Abutment Multi-Unit Abutment 3.5 Platform x 1mmH UCLA Gold Abutment 3.5 Platform (Engaging) 5.2 Posterior Straight Esthetic Abutment Multi-Unit Abutment 4.5 Platform x 5mmH Multi-Unit Prosthetic Screw Open-Tray Transfer 4.5 x 5.7 x 10 Closed-Tray Tranfer 3.5 x 3.5 x 8 Inclusive Multi-Unit Scan, Abutment UCLA Plastic 4.5 Platform (Non-engaging) 3.5 Anterior Straight Esthetic Abutment Cortical Bone Drill 1.5 Open-Tray Transfer 4.5 x 4.5 x 10 Torque/Ratchet Wrench Handpiece Implant Driver (short) Multi-Unit Impression Coping Open Inclusive Tapered Implant Conversion Kit Pilot Drill 2.3/2 Short Handpiece Hex Driver (short) Abutment screw (5/pk) Open-Tray Transfer 3.5 x 3.5 x 10 Multi-Unit Temporary Abutment with Guide Pin Implant Driver (short) Temporary Healing Cap Scanning Abutment 4.5 Platform Long (3/pk) Surgical Drill 4.9/4.4 Long Surgical Drill 4.4/3.8 Long Parallel Pin Inclusive Scanning Abutments Kit Surgical Instrument Tray Complete UCLA Plastic Platform (Engaging) Multi-Unit Abutment 4.5 Platform x 2mmH Multi-Unit Plastic Coping Abutment Screw Surgical Drill 4.4/3.8 Short Implant Analog 3.5 Multi-Unit Impression Copihng Closed Implant Analog 4.5 Multi-Unit Abutment 4.5 Platform x 3mmH Closed-Tray Impression Screw Lab Screw, 1-72 3.5 Anterior Angled Esthetic Abutment Prosthetic Screw Screw Tap 3.7 3mm Abutment 3.5mm x 3mm Surgical Drill 3.4/2.8 Short Scanning Abutment 3.5 Posterior Drill Extender Multi-Unit Healing Cap Handpiece Hex Driver (long) 4.5 Posterior Straight Esthetic Abutment Multi-Unit Guide Pin Scanning Abutment 3.5 Platform, long (3/pk) 3mm Abutment 3.5mm x 6mm Temporary Abutment 3.5mm Non-engaging Surgical Drill 3.4/2.8 Long Open-Tray Transfer 3.5 x 4.7 x 10 Surgical Drill 3.8/3.4 Long Temporary Abutment 4.5mm Non-engaging Right Angle Driver Cortical Bone Drill 2.4 Multi-Unit Abutment 4.5 Platform x 1mmH Cortical Bone Drill 1.7 Screw Tap 4.7 Round-Square Wrenchy Adaptor Surgical Drill 3.8/3.4 Short Multi-Unit Gold Plastic Bar Coping UCLA Plastic 4.5 Platform (Engaging) Closed-Tray Transfer 3.5 x 4.7 x 8 Cover Screw 3.5 Screw Tap 5.2 Multi-Unit Abutment 3.5 Platform x 2mmH Closed-Tray Transfer 4.5 x 5.7 x 8 Radiographic Template Temporary Abutment 3.5mm Engaging

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device