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510(k) Data Aggregation

    K Number
    K232271
    Device Name
    SIMDA abutment
    Manufacturer
    Date Cleared
    2023-10-26

    (87 days)

    Product Code
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Simda Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SIMDA Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
    Device Description
    SIMDA Abutment is made of titanium alloy (Ti-6Al-4V ELI, ASTM F136) intended for use as an aid in prosthetic restoration. It consists of Pre-Milled Blank and Ti-Base abutment. It has a premanufactured connection interface that fits directly to an endosseous dental implant.
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    K Number
    K223663
    Device Name
    SIMDA Abutment
    Manufacturer
    Date Cleared
    2023-05-24

    (168 days)

    Product Code
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIMDA Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SIMDA Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. It is compatible with the following systems: Compatible System Implant Body Diameter(mm) Implant Platform Osstem TS (K121995) 3.5, 3.75 Mini Osstem TS (K121995) 3.75, 3.77, 4.2, 4.25, 4.4, 4.6, 4.63, 4.65, 4.9, 5.05, 5.08, 5.1 Regular Straumann Bone Level (only the Roxolid® implants from K140878) 3.3 NC Straumann Bone Level (only the Roxolid® implants from K140878) 4.1, 4.8 RC All digitally designed abutments for use with SIMDA Abutments are intended to be sent to a SIMDA validated milling center for manufacture.
    Device Description
    SIMDA Abutment is made of titanium alloy (Ti-6A1-4V ELI. ASTM F136) intended for use as an aid in prosthetic restoration. It consists of Pre-Milled Blank and Ti-Base abutment. It has a premanufactured connection interface that fits directly to an endosseous dental implant. Pre-Milled Blank Design Limitation for Patient-specific abutment: Design parameter (Patient-specific abutment) Subject System Design Limit Minimum and Maximum Gingival (Cuff) Height 0.5~5mm Minimum and Maximum diameter at abutment/implant interface ⌀4.0~⌀8.0 Minimum and Maximum length of abutment 4.5~13mm Minimum and Maximum length of abutment post (length above the abutment collar/gingival height) 4~8mm Minimum wall thickness at abutment/implant interface 0.4mm Minimum and Maximum abutment angle 0~25° Ti Base consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM-designed zirconia superstructure (the second part of the two-piece abutment) that composes the final abutment. Pre-Milled Blank and Ti Base are provided non-sterile therefore must be sterilized after the cementation of the patient-specified superstructure. Raw material blanks - InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, cleared under K123664. ● Cement - . RelyX Unicem 2Automix by 3M ESPE, cleared under K100756. Design Limitation for Zirconia superstructure: Design Limits for Zirconia top-half (Min. ~ Max.) - Post Angle (°): 0~15 - Cuff Height (mm): 0.5~5.0 -Post Length (mm): 4.0~6.0 -Diameter (Ø, mm): 5.0~8.0 -Thickness (mm): 0.4
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