BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Inclusive Titanium Scanning Abutment Screw c/w: Straumann Tissue Level RN/WN synOcta

    Reg #: 3011649314 · FEI: 3011649314 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    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
    K151798

    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 Scanning Abutment Screw c/w: Straumann Tissue Level RN/WN synOcta Inclusive Titanium Abutment Blank compatible with: Straumann Tissue Level RN synOcta Inclusive Titanium Abutment 6 mmH c/w: Straumann Tissue Level WN synOcta Inclusive Titanium Abutment 6 mmH c/w: Straumann Tissue Level RN synOcta Inclusive Titanium Abutment 4.5 mmH c/w: Straumann Tissue Level WN synOcta Inclusive Multi-Unit Abut. 1.5 mmH compatible with: Straumann WN synOcta Titanium Basal Screw (5-pack) compatible with: Straumann Tissue Level RN/WN synOcta Inclusive Titanium Abutment Blank compatible with: Straumann Tissue Level WN synOcta Inclusive Multi-Unit Abut. 1 mmH compatible with: Straumann RN synOcta Inclusive Titanium Scanning Abutment Screw c/w: Straumann Bone Level NC/RC Inclusive Titanium Abutment 4.5 mmH c/w: Straumann Tissue Level RN synOcta Inclusive GL Titanium Abutment 4.5 mmH compatible with: Straumann Tissue Level RN synOcta Inclusive UCLA Gold Abutment, Non-Engaging, compatible with: Straumann WN synOcta Inclusive GL Titanium Abutment 4.5 mmH compatible with: Straumann Tissue Level WN synOcta Inclusive GL Titanium Abutment 6 mmH compatible with: Straumann Tissue Level WN synOcta Inclusive GL Titanium Abutment 6 mmH compatible with: Straumann Tissue Level RN synOcta Inclusive UCLA Gold Abutment, Non-Engaging, compatible with: Straumann RN synOcta

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device