BEUDAMED
    FDA Registration Active 🇺🇸 United States

    6 mm Abutment for CAMLOG SCREW-LINE 5 mm

    Reg #: 3011649314 · FEI: 3011649314 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    104
    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
    K121391

    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

    6 mm Abutment for CAMLOG SCREW-LINE 5 mm 6 mm Abutment for CAMLOG SCREW-LINE 4.3 mm Inclusive Titanium Abutment 3 mmH compatible with: Camlog Screw-Line 3.8 mm 4.5 mm Abutment Engaging for CAMLOG SCREW-LINE 4.3 mm 4.5 mm Abutment Non-Engaging for CAMLOG SCREW-LINE 3.8 mm Multi-Unit Abutment 2 mmH for CAMLOG SCREW-LINE 5 mm Inclusive Titanium Abutment Blank for CAMLOG SCREW-LINE 3.3 mm Inclusive Titanium Abutment 4.5 mmH compatible with: Camlog Screw-Line 5 mm 30 Degree Multi-Unit Abutment 5 mmH compatible with: Camlog Screw-Line 3.8 mm Inclusive Titanium Abutment 4.5 mmH compatible with: Camlog Screw-Line 3.3 mm 6 mm Abutment for CAMLOG SCREW-LINE 3.8 mm 30 Degree Multi-Unit Abutment 3 mmH compatible with: Camlog Screw-Line 4.3 mm Inclusive GL Titanium Abutment 6 mmH compatible with: Camlog Screw-Line 6 mm Inclusive Titanium Abutment Blank for CAMLOG SCREW-LINE 5 mm Inclusive 15 Degree Titanium Esthetic Abutment, Anterior, compatible with: Camlog Screw-Line 4.3 mm Esthetic Abutment, Anterior, Straight for CAMLOG SCREW-LINE 3.3 mm Esthetic Abutment, Anterior, Straight for CAMLOG SCREW-LINE 4.3 mm Multi-Unit Abutment 1 mmH compatible with: CAMLOG SCREW-LINE 4.3 mm Inclusive Titanium Screw compatible with: Camlog Screw-Line 3.3/3.8/4.3 mm Inclusive GL Titanium Abutment 6 mmH compatible with: Camlog Screw-Line 5 mm 4.5 mm Abutment Engaging for CAMLOG SCREW-LINE 5 mm Inclusive Titanium Abutment Blank compatible with: Camlog Screw-Line 5 mm Inclusive Titanium Abutment 3 mmH compatible with: Camlog Screw-Line 5 mm Inclusive Titanium Abutment 6 mmH compatible with: Camlog Screw-Line 3.8 mm Inclusive Titanium Esthetic Abutment, Posterior, compatible with: Camlog Screw-Line 4.3 mm Esthetic Abutment, Anterior, 15 Degree Angle for CAMLOG SCREW-LINE 3.8 mm Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Camlog Screw-Line 4.3 mm Inclusive 15 Degree Titanium Esthetic Abutment, Anterior, compatible with: Camlog Screw-Line 3.8 mm Inclusive Titanium Abutment Blank for CAMLOG SCREW-LINE 6 mm Esthetic Abutment, Posterior, 15 Degree Angle for CAMLOG SCREW-LINE 5 mm 17 Degree Multi-Unit Abutment 3 mmH compatible with: Camlog Screw-Line 4.3 mm 30 Degree Multi-Unit Abutment 3 mmH compatible with: Camlog Screw-Line 3.8 mm 4.5 mm Abutment Non-Engaging for CAMLOG SCREW-LINE 3.3 mm Multi-Unit Abutment 2 mmH compatible with: CAMLOG SCREW-LINE 4.3 mm Inclusive Titanium Esthetic Abutment, Anterior, compatible with: Camlog Screw-Line 3.3 mm 6 mm Abutment for CAMLOG SCREW-LINE 6 mm Inclusive GL Titanium Abutment 4.5 mmH compatible with: Camlog Screw-Line 4.3 mm Inclusive Titanium Abutment 6 mmH compatible with: Camlog Screw-Line 4.3 mm Multi-Unit Abutment 1 mmH compatible with: CAMLOG SCREW-LINE 3.8 mm Multi-Unit Abutment 3 mmH for CAMLOG SCREW-LINE 5 mm Inclusive Titanium Abutment Blank compatible with: Camlog Screw-Line 3.8 mm Multi-Unit Abutment 5 mmH for CAMLOG SCREW-LINE 4.3 mm Inclusive Titanium Abutment Blank compatible with: Camlog Screw-Line 6 mm Inclusive Titanium Abutment 6 mmH compatible with: Camlog Screw-Line 3.3 mm 3 mm Abutment for CAMLOG SCREW-LINE 5 mm 17 Degree Multi-Unit Abutment 2 mmH compatible with: Camlog Screw-Line 4.3 mm Inclusive Titanium Abutment 3 mmH compatible with: Camlog Screw-Line 6 mm 6 mm Abutment for CAMLOG SCREW-LINE 3.3 mm 30 Degree Multi-Unit Abutment 5 mmH compatible with: Camlog Screw-Line 4.3 mm Inclusive GL Titanium Abutment 4.5 mmH compatible with: Camlog Screw-Line 5 mm Inclusive Titanium Abutment 3 mmH compatible with: Camlog Screw-Line 3.3 mm Inclusive Titanium Esthetic Abutment, Anterior, compatible with: Camlog Screw-Line 4.3 mm Inclusive Titanium Abutment 6 mmH compatible with: Camlog Screw-Line 6 mm 17 Degree Multi-Unit Abutment 5 mmH compatible with: Camlog Screw-Line 4.3 mm 4.5 mm Abutment Non-Engaging for CAMLOG SCREW-LINE 6 mm Inclusive Angled Multi-Unit Abutment Screw compatible with: Camlog Screw Line 3.3/3.8/4.3 mm 3 mm Abutment for CAMLOG SCREW-LINE 3.3 mm 4.5 mm Abutment Non-Engaging for CAMLOG SCREW-LINE 5 mm Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Camlog Screw-Line 6 mm Inclusive Titanium Esthetic Abutment, Posterior, compatible with: Camlog Screw-Line 5 mm Inclusive 15 Degree Titanium Esthetic Abutment, Anterior, compatible with: Camlog Screw-Line 3.3 mm Inclusive Titanium Abutment Blank compatible with: Camlog Screw-Line 3.3 mm Inclusive Titanium Screw (5-pack) compatible with: Camlog Screw-Line 5/6 mm Inclusive Titanium Abutment 3 mmH compatible with: Camlog Screw-Line 4.3 mm Inclusive GL Titanium Abutment 4.5 mmH compatible with: Camlog Screw-Line 6 mm Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Camlog Screw-Line 3.8 mm 3 mm Abutment for CAMLOG SCREW-LINE 3.8 mm 3 mm Abutment for CAMLOG SCREW-LINE 4.3 mm Inclusive Titanium Esthetic Abutment, Anterior, compatible with: Camlog Screw-Line 3.8 mm Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Camlog Screw-Line 5 mm Inclusive GL Titanium Abutment 4.5 mmH compatible with: Camlog Screw-Line 3.8 mm Inclusive Titanium Abutment 6 mmH compatible with: Camlog Screw-Line 5 mm Inclusive Titanium Abutment Blank for CAMLOG SCREW-LINE 4.3 mm Esthetic Abutment, Anterior, 15 Degree Angle for CAMLOG SCREW-LINE 3.3 mm Inclusive Titanium Abutment Blank compatible with: Camlog Screw-Line 4.3 mm Inclusive GL Titanium Abutment 6 mmH compatible with: Camlog Screw-Line 4.3 mm Inclusive Titanium Abutment 4.5 mmH compatible with: Camlog Screw-Line 6 mm 17 Degree Multi-Unit Abutment 2 mmH compatible with: Camlog Screw-Line 3.8 mm Inclusive GL Titanium Abutment 6 mmH compatible with: Camlog Screw-Line 3.8 mm Inclusive Titanium Abutment Blank for CAMLOG SCREW-LINE 3.8 mm Inclusive GL Titanium Abutment 4.5 mmH compatible with: Camlog Screw-Line 3.3 mm Esthetic Abutment, Posterior, 15 Degree Angle for CAMLOG SCREW-LINE 4.3 mm Inclusive GL Titanium Abutment 6 mmH compatible with: Camlog Screw-Line 3.3 mm Esthetic Abutment, Posterior, Straight for CAMLOG SCREW-LINE 5 mm Inclusive 15 Degree Titanium Esthetic Abutment, Posterior, compatible with: Camlog Screw-Line 5 mm 4.5 mm Abutment Engaging for CAMLOG SCREW-LINE 6 mm Esthetic Abutment, Posterior, Straight for CAMLOG SCREW-LINE 4.3 mm Inclusive Titanium Screw compatible with: Camlog Screw-Line 5/6 mm 4.5 mm Abutment Non-Engaging for CAMLOG SCREW-LINE 4.3 mm Multi-Unit Abutment 2 mmH compatible with: CAMLOG SCREW-LINE 3.8 mm 4.5 mm Abutment Engaging for CAMLOG SCREW-LINE 3.3 mm 3 mm Abutment for CAMLOG SCREW-LINE 6 mm Inclusive Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Camlog Screw-Line 3.3 mm Esthetic Abutment, Anterior, 15 Degree Angle for CAMLOG SCREW-LINE 4.3 mm Inclusive Titanium Abutment 4.5 mmH compatible with: Camlog Screw-Line 3.8 mm Inclusve Titanium Screw (5-pack) compatible with: Camlog Screw-Line 3.3/3.8/4.3 mm Inclusive Titanium Abutment 4.5 mmH compatible with: Camlog Screw-Line 4.3 mm Multi-Unit Abutment 1 mmH compatible with: CAMLOG SCREW-LINE 5 mm Multi-Unit Abutment 3 mmH for CAMLOG SCREW-LINE 3.8 mm Inclusive 15 Degree Titanium Esthetic Abutment, Posterior, compatible with: Camlog Screw-Line 4.3 mm Multi-Unit Abutment 3 mmH for CAMLOG SCREW-LINE 4.3 mm Esthetic Abutment, Anterior, Straight for CAMLOG SCREW-LINE 3.8 mm 4.5 mm Abutment Engaging for CAMLOG SCREW-LINE 3.8 mm 17 Degree Multi-Unit Abutment 3 mmH compatible with: Camlog Screw-Line 3.8 mm

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198