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510(k) Data Aggregation

    K Number
    K171622
    Device Name
    Dentium Ti-Base
    Manufacturer
    Dentium Co., Ltd.
    Date Cleared
    2018-01-11

    (223 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K161713,K041368,K160965,K150367
    Why did this record match?
    Device Name :

    Dentium Ti-Base

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

    Dentium Ti-Base abutments are intended for use on Dentium endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.

    All digitally designed abutments for use with Dentium Ti-Base abutments are intended to be sent to a Dentium-validated milling center for manufacture.

    Device Description

    Dentium Ti-Base is a patient specific abutment fabricated by Dentium and composed of unalloyed titanium and zirconia ceramic. The Ti-Base has a titanium pre-manufactured precision abutment/implant interface and ceramic superstructure bonded to the post of the titanium base. Ti-Base is used for support of CAD/CAM fabricated zirconia superstructures or for support of hybrid crowns or bridges. Hybrid crowns or bridges and zirconia superstructures are manufactured by a Dentium validated milling center.

    Ti-Base Abutments are available in two prosthetic diameters (4.5 and 5.5 mm) and four gingival heights (0.5, 1.0, 1.5, and 2.0 mm). Each of the abutments is available indexed and non-indexed. All subject device abutments are compatible with Dentium and Dentium Superline dental implants.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the Dentium Ti-Base dental abutment, establishing its substantial equivalence to previously marketed predicate devices. This type of submission relies on non-clinical performance data rather than extensive clinical studies with specific acceptance criteria as might be seen for novel devices.

    Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (What was measured)Device Performance (Result)
    Sterilization ValidationAccording to ISO 17665-2 to an SAL of 10⁻⁶
    CytotoxicityAccording to ISO 10993-5, determining the subject device is non-cytotoxic
    Dynamic Compression-Bending StrengthAccording to ISO 14801, ensuring that the subject device is strong enough for its intended use (Specific values not provided)
    Substantial Equivalence (Indications for Use)Determined to be substantially equivalent to predicate devices (K150367, K161713)
    Substantial Equivalence (Design, Function, Material, Manufacture)Determined to be substantially equivalent to predicate devices, with minor differences in design dimensions and implant/abutment interface noted for K150367 and K161713. Materials are similar (Unalloyed Titanium ASTM F67, Zirconia ISO 13356).
    Substantial Equivalence (Physical Dimensions)Encompasses the same range of physical dimensions (diameter, gingival height, angle of abutments) as predicate devices.

    2. Sample Sizes and Data Provenance

    • Test Set Sample Size: Not explicitly stated for any of the non-clinical tests. For ISO 14801, typical sample sizes are small (e.g., n=5 or n=10 per test condition), but this is not specified.
    • Data Provenance: The studies are non-clinical (laboratory/mechanical testing). The manufacturer is Dentium Co., Ltd. in the Republic of Korea. Therefore, the data originates from the manufacturer's testing or a contracted testing facility. All data is presumably prospective as it was generated to support the 510(k) submission.

    3. Number of Experts and Qualifications for Ground Truth

    • This information is not applicable as the studies are non-clinical performance tests for a device seeking substantial equivalence, not a diagnostic algorithm requiring expert-established ground truth. The "ground truth" for these tests is defined by the standards (ISO 17665-2, ISO 10993-5, ISO 14801).

    4. Adjudication Method for the Test Set

    • This information is not applicable as the studies are non-clinical performance tests and do not involve human adjudication for a "test set" in the context of diagnostic assessment.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical dental abutment, not a diagnostic AI system that would assist human readers.

    6. Standalone (Algorithm Only) Performance Study

    • No, a standalone (algorithm only) performance study was not done. The device is a physical medical device. The "digitally designed abutments" mentioned refer to CAD/CAM processes used in manufacturing, but this is a manufacturing method, not an AI algorithm requiring standalone performance evaluation in the medical sense.

    7. Type of Ground Truth Used

    • The "ground truth" applied here is primarily established international standards for medical device testing (e.g., ISO 17665-2 for sterilization, ISO 10993-5 for cytotoxicity, ISO 14801 for mechanical strength). For substantial equivalence, the performance is compared against the characteristics of legally marketed predicate devices.

    8. Sample Size for the Training Set

    • This information is not applicable. The device is a physical product, not an AI/ML algorithm that is "trained" on a dataset. The manufacturing process might involve CAD/CAM software, but this is distinct from an AI training set.

    9. How the Ground Truth for the Training Set Was Established

    • This information is not applicable as there is no "training set" in the context of an AI/ML algorithm.
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