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    K Number
    K251605

    Validate with FDA (Live)

    Device Name
    DIMPLO Implant System
    Manufacturer
    Dimplo , Ltd.
    Date Cleared
    2025-12-22

    (209 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K161987,K141457,K231426,K161689,K223924,K231753,K231411,K220253,K210117,K231395,K201323,K161713,K181138
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K161987, K141457, K231426, K161689, K223924, K231753, K231411, K220253, K210117, K231395, K201323, K161713

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DIMPLO Implant System is intended for use in the maxilla or mandible of partially or fully edentulous patients to support single or multiple-unit restorations, including cemented, screw-retained, or overdenture restorations, as well as terminal or intermediate abutment support for fixed bridgework. It is intended for two-stage surgical procedures and may be used for immediate loading when good primary stability and appropriate occlusal loading conditions are achieved.

    • Ø3.3 mm implants are for replacing maxillary lateral incisors and mandibular incisors with delayed loading only.
    • Ø5.0 mm and larger implants are intended for delayed loading in the molar region.

    All digitally designed custom components (including Ti-Base and Pre-milled Blanks) for use with the DIMPLO Implant System are to be manufactured at a DIMPLO validated milling center.

    Device Description

    The DIMPLO Implant System consists of fixtures, abutments, and attachments designed for dental implant procedures.

    Fixture: Made of unalloyed titanium (Grade 4, ASTM F67), these dental implants are available in a range of diameters and lengths to accommodate various clinical applications in the maxilla and mandible. The surface is treated with SLA (Sandblasted, Large grit, and Acid-etched) and provided sterile via gamma irradiation. Available in two platform sizes: Mini and Regular.

    Abutment: These components aid in prosthetic restorations. This category includes Cover Screws, Healing Abutments, Temporary Abutments, Cemented Abutments, Angled Abutments, Ti-Base, Pre-milled Blanks, Screws, Multi-unit Abutments, Healing Caps, and Cylinders.

    Attachments: Includes Locatus Male Cap and Locatus Retention Male. The Locatus Male Cap is made of titanium alloy (Ti-6Al-4V ELI), while the Locatus Retention Male is made of nylon.

    Fixtures and cover screws are supplied sterile. All other abutments and attachments are provided non-sterile and must be sterilized by the end user before use.

    Ti-Base consists of a two-piece abutment that includes a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient-specific superstructure) at the top, composing the final abutment.

    Superstructure and Bonding Materials

    • Zirconia material: InCoris Zi (ZrO₂) (K123664, Sirona Dental Systems GmbH)
    • Bonding agent: RelyX Unicem 2 Automix (K100756, 3M ESPE)

    Design Envelope for Zirconia superstructure

    Dimensional CharacteristicsRange/Limit
    Post Angle (°)0~20
    Cuff Height (mm)0.5~5.0
    Abutment Post Height (mm)4.0~6.0
    Diameter (Ø , mm)5.0~8.0
    Wall Thickness (mm)0.4~

    Design Envelope for Pre-milled Blank

    Dimensional CharacteristicsRange/Limit
    Post Angle (°)0~30
    Cuff Height (mm)0.5~6.0
    Abutment Post Height (mm)4.0~7.0
    Diameter (Ø , mm)3.5~6.5
    Wall Thickness (mm)0.4~

    Note: Abutment Post Height is defined as the minimum cementable post height for single-unit restoration, measured as the height above the restorative margin.

    AI/ML Overview

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