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510(k) Data Aggregation

    K Number
    K252320

    Validate with FDA (Live)

    Device Name
    SIMDA Abutments
    Manufacturer
    Simda Co., Ltd.
    Date Cleared
    2025-12-18

    (146 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K130999,K120414,K024111,K101732,K093321,K143022,K071638,K130949,K173961,K181703,K191256,K200817,K123664,K100756,K223663
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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:

    Pre-Milled Blank, Patient-specific abutment

    Compatible SystemImplant Body Diameter(mm)Implant Platform
    Astra OsseoSpeed® EV (K120414, K130999)3.0, 3.6, 4.2, 4.8, 5.43.0, 3.6, 4.2, 4.8, 5.4
    Astra Tech Implant System (K101732) Astra Tech OsseoSpeed Astra Tech Fixture MicroMacro (New indication) (K024111)3.0S, 3.5S, 4.0S, 4.5, 5.0, 5.0S3.0(x-small), 3.5/4.0(small), 4.5/5.0(large)
    BioHorizons Laser-Lok 3.0 Implant System (K093321) BioHorizons Tapered Internal Implant System (K143022, K071638)3.0, 3.4, 3.8, 4.6, 5.83.0, 3.4, 3.8, 4.6, 5.8
    Biomet 3i Certain® (K130949)3.25, 4.0, 5.0, 6.03.25, 4.0, 5.0, 6.0
    Straumann BLX Implant (K173961, K181703, K191256)3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5RB, WB

    Ti-Base abutment

    Compatible SystemImplant Body Diameter(mm)Implant Platform
    BioHorizons Laser-Lok 3.0 Implant System (K093321) BioHorizons Tapered Internal Implant System (K143022, K071638)3.0, 3.4, 3.8, 4.6, 5.83.0, 3.4, 3.8, 4.6, 5.8
    Biomet 3i Certain® (K130949)3.25, 4.0, 5.0, 6.03.25, 4.0, 5.0, 6.0
    Straumann BLX Implant (K173961, K181703, K191256)3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5RB, WB

    Multi-unit abutment

    Compatible SystemImplant Body Diameter(mm)Implant Platform
    Straumann BLX Implant (K173961, K181703, K191256)3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5RB, WB

    Multi-unit Abutment is only compatible with Straumann BLX Implant System.

    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 intended for use as an aid in prosthetic restoration. It consists of Pre-Milled Blank, Ti-Base, Multi-unit Abutment, Multi-unit Base. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant.

    Pre-milled Blank Design
    This device is a patient-specific abutment composed of titanium alloy (Ti-6Al-4V ELI, ASTM F136) which is designed by a clinician or lab, and milled at a SIMDA validated milling center.

    Pre-Milled Blank Design Limitation for Patient-specific abutment:

    Design parameter (Patient-specific abutment)Subject System Design Limit
    Minimum and Maximum Gingival (Cuff) Height0.5~5mm
    Minimum and Maximum diameter at abutment/implant interface4.0~8.0
    Minimum and Maximum length of abutment6~12mm
    Minimum and Maximum length of abutment post (length above the abutment collar/gingival height)4~8mm
    Minimum wall thickness at abutment/implant interface0.32 (Astra EV), 0.32 (Astra TX), 0.39 (BioHorizons), 0.4 (Biomet 3i), 0.42 (Straumann BLX)
    Minimum and Maximum abutment angle015º (Astra EV and Astra TX), 025º (BioHorizons, Biomet 3i, and Straumann BLX)

    Pre-Milled Blank Design Limitation for Patient-specific abutment:
    Astra OsseoSpeed EV, Astra Tech OsseoSpeed TX is minimum and maximum abutment angle 0~15 º

    Ti-Base Abutment
    Ti Base consists of a two-piece abutment, where the titanium base is a pre-manufactured titanium component 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.

    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 ParameterLimit (Min.~Max.)
    Minimum and Maximum abutment angle0~15
    Minimum and Maximum Gingival (Cuff) Height0.5~5.0
    Minimum and Maximum length of abutment post (length above the abutment collar/gingival height)4.0~6.0
    Minimum and Maximum diameter at abutment/implant interface5.0~8.0
    Minimum wall thickness at abutment/implant interface0.33

    Multi-unit Abutment and Base
    Multi-unit Abutment which are placed into the dental implant to provide support for the prosthetic restoration. The abutments are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F136). The Multi-unit Abutment has a post height less than 4mm and are always combined with Multi-unit Base, increasing the post height to a minimum of 4.5mm.

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