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510(k) Data Aggregation

    K Number
    K173701
    Device Name
    Implant-One System
    Manufacturer
    Implant Logistics, Inc.
    Date Cleared
    2018-11-29

    (360 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K083805,K131644,K072570,K161435,K143051,K150295,K990277,K150537,K102822
    Why did this record match?
    Reference Devices :

    K083805, K131644, K072570, K161435, K143051, K150295, K990277, K150537

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

    The Implant-One™ System is indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The Implant-One™ system is indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.

    Device Description

    Endosseous implants are self-tapping and threaded, and offered having root-form or wide thread forms. Root-form implant diameters range from 3.25mm to 5.5mm having lengths from 8mm to 14mm. Wide thread implant diameters are available in 4.1 and 4.5mm (8mm to 14mm lengths), 5.5mm (8mm to 12mm lengths) and 6.5mm (8mm to 10mm lengths). Cover screws and healing caps provide protection to the threads of the abutment connection during endosseous and gingival healing. Cover screws are pre- packaged with each implant. Healing caps are provided as an alternative to the cover screw and are packaged separately. The Implant-One™ dental implants and cover screws are provided sterile. Not all abutments can be used for single-unit restorations. The conical, angled conical, ball, locator and glueless abutments are intended only for multi-unit loaded restorations. The ball, locator and glueless abutments are to be used in fully removable dentures. The conical and angled conical abutments are to be used in screw retained dentures and with the titanium sleeve for screw retention. The final design parameters for the custom blank abutment are as follows: maximum total height, 12.5mm; minimum/maximum gingival height, 0.5mm/6mm; minimum post height, 4mm; maximum angulation, 30°; minimum wall thickness, 0.78 (at 1.5mm above the proximal end); minimum diameter, 3.75 mm for the 300 Series, 4.25 mm for the 300 Series and 4.75 mm for the 500 Series.

    AI/ML Overview

    The provided text is a 510(k) summary for the Implant-One™ System, a dental implant device. It demonstrates the device's substantial equivalence to existing legally marketed predicate devices through non-clinical performance data.

    However, the document does not describe a study involving an algorithm, AI assistance, human readers, or any form of "acceptance criteria" related to diagnostic performance or accuracy as one would expect for an AI/ML medical device.

    Instead, the "acceptance criteria" and "study" described in this document pertain to engineering and biocompatibility performance of a physical medical device (dental implants and abutments), not a software or AI-driven system.

    Therefore, for each of the requested points, the answer is that the information is not applicable (N/A) in the context of this document, as it describes a physical dental implant system and not an AI/ML device that would have such performance criteria.

    Here's how to address each point based on the provided text:

    Acceptance Criteria and Device Performance (Based on Device Type - Dental Implants)

    Since this is for a physical dental implant system, the "acceptance criteria" are related to mechanical integrity, biocompatibility, sterilization, and packaging/shelf-life, rather than diagnostic accuracy. The "device performance" indicates that the device met these criteria by demonstrating substantial equivalence to predicates.

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

    Acceptance Criteria CategorySpecific Acceptance Criteria (Demonstrated Equivalence To)Reported Device Performance
    Mechanical PerformanceISO 14801 (for worst-case construct performance)"Non-clinical mechanical testing of the worst case Implant-One™ System construct was performed according to ISO 14801 and demonstrated that the Implant-One™ system performs as well as or better than the predicate devices."
    BiocompatibilityISO 10993-5"Biocompatibility testing was performed according to ISO 10993-5 and demonstrated substantial equivalence."
    SterilizationISO 11137 and ISO 17665"Sterilization validations were performed according to ISO 11137 and 17665 and demonstrated substantial equivalence."
    Packaging & Shelf-lifeASTM D4169 (including ASTM F1886, ASTM F88, and ASTM F1929)"Packaging and shelf-life validations were performed according to ASTM D4169 including ASTM F1886, ASTM F88 and ASTM F1929 and demonstrated substantial equivalence."
    Endotoxin Limit
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