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510(k) Data Aggregation

    K Number
    K200193
    Device Name
    Kisses Plus Implant System
    Manufacturer
    ACHIMHAI Medical Corporation
    Date Cleared
    2021-08-06

    (557 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K161416,K112045,K142813,K172630,K072570
    Why did this record match?
    Reference Devices :

    K161416, K112045, K142813, K172630

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

    The Kisses Plus Implant System is indicated for use in partially or fully edentulous mandibles and maxilla, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

    The Kisses Plus Implant System is for single and two stage surgical procedures. It is for delayed loading.

    Device Description

    This 510k is to add the following abutments to Kisses Plus Implant System: Multi Straight Abutment, Multi Angled Abutment, CCM Abutment, and Multi CCM Abutment. The description includes details on the material composition (Ti 6A14V ELI or Co Cr Mo) and dimension ranges for each abutment type. It also mentions the abutment screws used with these abutments.

    AI/ML Overview

    The provided text is a 510(k) summary for a dental implant system (Kisses Plus Implant System) and, as such, focuses on demonstrating substantial equivalence to predicate devices rather than reporting on the performance of an AI/ML powered device.

    Therefore, the document does not contain any information regarding:

    • Acceptance criteria for an AI/ML powered device.
    • Study details (e.g., test set sample size, provenance, expert qualifications, adjudication method, MRMC studies, standalone performance, ground truth type, training set details) that would prove an AI/ML device meets specific performance criteria.

    The document describes non-clinical testing performed for the Kisses Plus Implant System, which includes:

    • Fatigue test in accordance with ISO 14801.
    • Biocompatibility tests: Cytotoxicity, Sensitization, and Irritation tests per ISO 10993-5 and ISO 10993-10, with additional leveraging from K172630.
    • Steam sterilization validation in accordance with ISO 17665-1 and ISO 17665-2.

    These tests are designed to ensure the safety and effectiveness of the physical dental implant components and demonstrate substantial equivalence to predicate devices, not AI/ML performance.

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