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510(k) Data Aggregation

    K Number
    K163557
    Device Name
    SS SA Fixture
    Manufacturer
    OSSTEM IMPLANT Co., Ltd.
    Date Cleared
    2017-05-15

    (147 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K161604,K120847
    Why did this record match?
    Device Name :

    SS SA Fixture

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

    The Osstem Implant is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra Wide Fixture System is intended to be used in the molar region.

    Device Description

    The SS SA Fixture is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated.

    AI/ML Overview

    This document is a 510(k) Premarket Notification from Osstem Implant Co., Ltd. to the FDA for their "SS SA Fixture" dental implant. It aims to demonstrate substantial equivalence to legally marketed predicate devices rather than proving the device meets specific acceptance criteria through a study with performance metrics as one might see for a diagnostic AI device.

    Therefore, the requested information elements (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth types, training set size, and training ground truth establishment) are generally not applicable in the context of this 510(k) submission for a non-AI dental implant.

    However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish substantial equivalence.

    Here's an adaptation of the requested format based on the available information:

    1. A table of acceptance criteria and the reported device performance

    For a dental implant, "acceptance criteria" usually refers to meeting established standards (e.g., ISO, ASTM) and demonstrating equivalence to predicate devices, rather than specific performance metrics like sensitivity/specificity for an AI algorithm. The device performance is primarily assessed through non-clinical testing to ensure its physical and mechanical properties are comparable or superior to the predicate.

    Acceptance Criterion (Based on predicate equivalence and applicable standards)Reported Device Performance (SS SA Fixture)
    Material Composition (Pure Titanium Grade 4 per ASTM F67)Same as Predicate: Pure Titanium Grade 4 (ASTM F67)
    Surface Treatment (SA - Sandblasted and Acid etched)Same as Predicate: SA surface treatment. No change from predicate.
    Sterilization (Radiation Sterile)Same as Predicate: Radiation Sterile. No change from predicate.
    Shelf Life (Compared to predicate)Same as Reference Predicate: 8 years (Primary Predicate was 5 years, Reference Predicate was 8 years).
    Biocompatibility (As established for predicate material and processes)No additional testing required: Material of construction and manufacturing processes are the same as predicate devices (ET/SS Implant System, K120847 and OSSTEM Implant System, K161604).
    Bone to Implant Contact (BIC) Value (Comparable to predicate device with similar lengths)Substantial equivalence confirmed: BIC analysis conducted for implants
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