BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Straumann® BLX RB/WB

    Reg #: 3011649314 · FEI: 3011649314 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    106
    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
    K240240

    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 4.5 mmH, Non-Engaging, compatible with: Straumann® BLX RB/WB Inclusive® Titanium Abutment Blank compatible with: Neodent® GM Inclusive® Titanium Screw compatible with: Implant Direct® RePlant® 4.3/5/6 mm Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Implant Direct® Legacy® 5.7 mm Inclusive® Multi-Unit Coping 4.5 mmH compatible with: Keystone® Dental PrimaConnex® Inclusive® GL Titanium Abutment 6 mmH compatible with: Straumann® BLX RB/WB Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Implant Direct® InterActive® 3.4 mm Inclusive® Titanium Screw compatible with: Implant Direct® InterActive® 3 mm Inclusive® GL Titanium Abutment 4.5 mmH compatible with: Implant Direct® RePlant® 4.3 mm Inclusive® GL Titanium Abutment 6 mmH compatible with: Implant Direct® Legacy® 3 mm Inclusive® Multi-Unit Coping 8 mmH compatible with: Neodent® GM Abutment Inclusive® Titanium Abutment Blank compatible with: Implant Direct® Legacy® 3 mm Inclusive® Titanium Abutment Blank compatible with: Straumann® BLX RB/WB Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: Keystone® Dental PrimaConnex® RD Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Neodent® GM Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Implant Direct® Legacy® 3 mm Inclusive® GL Titanium Abutment 6 mmH compatible with: Implant Direct® RePlant® 4.3 mm Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: Keystone® Dental PrimaConnex® WD Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: Keystone® Dental PrimaConnex® SD Inclusive® GL Titanium Abutment 4.5 mmH compatible with: Implant Direct® RePlant® 3.5 mm Inclusive® GL Titanium Abutment 6 mmH compatible with: Implant Direct® Legacy® 5.7 mm Inclusive® GL Titanium Abutment 4.5 mmH compatible with: Implant Direct® Legacy® 5.7 mm Inclusive® Multi-Unit Coping 8 mmH compatible with: Keystone® Dental PrimaConnex® Inclusive® GL Titanium Abutment 4.5 mmH compatible with: Implant Direct® InterActive® 3.4 mm Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: Implant Direct® RePlant® 6 mm Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Implant Direct® Legacy® 4.5 mm Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Keystone® Dental PrimaConnex® WD Inclusive® GL Titanium Abutment 6 mmH compatible with: Implant Direct® Legacy® 3.5 mm Inclusive® Titanium Abutment Blank compatible with: Implant Direct® InterActive® 3 mm Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Implant Direct® InterActive® 3 mm Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Keystone® Dental PrimaConnex® SD Inclusive® Multi-Unit Coping 8 mmH compatible with: Neodent® GM Micro Conical Abutment Inclusive® Multi-Unit Coping 4.5 mmH compatible with: Implant Direct® Inclusive® GL Titanium Abutment 6 mmH compatible with: Straumann® BLX WB Inclusive® Titanium Screw compatible with: Implant Direct® RePlant® 3.5 mm Inclusive® Multi-Unit Coping 4.5 mmH compatible with: Neodent® GM Mini Conical Abutment Inclusive® Multi-Unit Coping 8 mmH compatible with: Neodent® GM Mini Conical Abutment Inclusive® Titanium Abutment Blank compatible with: Implant Direct® RePlant® 3.5 mm Inclusive® Multi-Unit Coping 8 mmH compatible with: Straumann® BLX Inclusive® GL Titanium Abutment 4.5 mmH compatible with: Straumann® BLX RB/WB Inclusive® Multi-Unit Coping 4.5 mmH compatible with: Straumann® BLX Inclusive® Multi-Unit Coping Screw compatible with: Straumann® BLX Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: Implant Direct® RePlant® 4.3 mm Inclusive® Titanium Screw compatible with: Implant Direct® Legacy® 3 mm Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: Implant Direct® Legacy® 3 mm Inclusive® Titanium Screw compatible with: Implant Direct® InterActive® 3.4 mm Inclusive® Titanium Screw compatible with: Keystone® Dental PrimaConnex® SD/RD/WD Inclusive® GL Titanium Abutment 6 mmH compatible with: Implant Direct® RePlant® 5 mm Inclusive® Titanium Abutment Blank compatible with: Implant Direct® Legacy® 5.7 mm Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: Implant Direct® Legacy® 5.7 mm Inclusive® GL Titanium Abutment 4.5 mmH compatible with: Straumann® BLX WB Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: Straumann® BLX WB Inclusive® Multi-Unit Coping Screw compatible with: Keystone® Dental PrimaConnex® Inclusive® Titanium Abutment Blank compatible with: Implant Direct® RePlant® 5 mm Inclusive® Titanium Abutment Blank compatible with: Implant Direct® InterActive® 3.4 mm Inclusive® GL Titanium Abutment 4.5 mmH compatible with: Keystone® Dental PrimaConnex® RD Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: Straumann® BLX RB/WB Inclusive® Multi-Unit Coping Screw compatible with: Implant Direct® Inclusive® Titanium Abutment Blank compatible with: Implant Direct® RePlant® 6 mm Inclusive® GL Titanium Abutment 4.5 mmH compatible with: Implant Direct® Legacy® 3 mm Inclusive® GL Titanium Abutment 4.5 mmH compatible with: Neodent® GM Inclusive® GL Titanium Abutment 4.5 mmH compatible with: Implant Direct® RePlant® 5 mm Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: Implant Direct® Legacy® 3.5 mm Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: Neodent® GM Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Implant Direct® Legacy® 3.5 mm Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Implant Direct® RePlant® 3.5 mm Inclusive® Titanium Abutment Blank compatible with: Implant Direct® RePlant® 4.3 mm Inclusive® GL Titanium Abutment 6 mmH compatible with: Keystone® Dental PrimaConnex® WD Inclusive® GL Titanium Abutment 6 mmH compatible with: Neodent® GM Inclusive® GL Titanium Abutment 4.5 mmH compatible with: Keystone® Dental PrimaConnex® WD Inclusive® Titanium Screw compatible with: Straumann® BLX RB/WB Inclusive® Titanium Abutment Blank compatible with: Straumann® BLX WB Inclusive® GL Titanium Abutment 6 mmH compatible with: Keystone® Dental PrimaConnex® RD Inclusive® GL Titanium Abutment 4.5 mmH compatible with: Keystone® Dental PrimaConnex® SD Inclusive® Multi-Unit Coping 4.5 mmH compatible with: Neodent® GM Micro Conical Abutment Inclusive® GL Titanium Abutment 4.5 mmH compatible with: Implant Direct® Legacy® 3.5 mm Inclusive® Multi-Unit Coping 8 mmH compatible with: Implant Direct® Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Straumann® BLX WB Inclusive® Titanium Screw compatible with: Implant Direct® Legacy® 3.5/4.5/5.7 mm Inclusive® GL Titanium Abutment 6 mmH compatible with: Implant Direct® InterActive® 3 mm Inclusive® GL Titanium Abutment 6 mmH compatible with: Implant Direct® InterActive® 3.4 mm Inclusive® Multi-Unit Coping Screw compatible with: Neodent® GM Mini & Micro Conical Abutment Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: Implant Direct® Legacy® 4.5 mm Inclusive® GL Titanium Abutment 6 mmH compatible with: Keystone® Dental PrimaConnex® SD Inclusive® GL Titanium Abutment 4.5 mmH compatible with: Implant Direct® RePlant® 6 mm Inclusive® Titanium Abutment Blank compatible with: Keystone® Dental PrimaConnex® RD Inclusive® GL Titanium Abutment 6 mmH compatible with: Implant Direct® Legacy® 4.5 mm Inclusive® Titanium Abutment Blank compatible with: Keystone® Dental PrimaConnex® WD Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: Implant Direct® InterActive® 3.4 mm Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: Implant Direct® RePlant® 5 mm Inclusive® GL Titanium Abutment 4.5 mmH compatible with: Implant Direct® Legacy® 4.5 mm Inclusive® GL Titanium Abutment 6 mmH compatible with: Implant Direct® RePlant® 3.5 mm Inclusive® Multi-Unit Coping Screw compatible with: Neodent® GM Abutment Inclusive® Titanium Abutment Blank compatible with: Implant Direct® Legacy® 4.5 mm Inclusive® Titanium Screw compatible with: Neodent® GM Inclusive® GL Titanium Abutment 6 mmH compatible with: Implant Direct® RePlant® 6 mm Inclusive® GL Titanium Abutment 4.5 mmH compatible with: Implant Direct® InterActive® 3 mm Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: Implant Direct® RePlant® 3.5 mm Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Keystone® Dental PrimaConnex® RD Inclusive® Multi-Unit Coping 4.5 mmH compatible with: Neodent® GM Abutment Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Implant Direct® RePlant® 5 mm Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Implant Direct® RePlant® 4.3 mm Inclusive® Titanium Abutment 6 mmH, Non-Engaging, compatible with: Implant Direct® InterActive® 3 mm Inclusive® Titanium Abutment Blank compatible with: Keystone® Dental PrimaConnex® SD Inclusive® Titanium Abutment Blank compatible with: Implant Direct® Legacy® 3.5 mm Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Implant Direct® RePlant® 6 mm

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device