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510(k) Data Aggregation

    K Number
    K160248
    Device Name
    ArgenIS Titanium Abutments
    Manufacturer
    Argen Corporation
    Date Cleared
    2016-08-05

    (186 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Abbreviated
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K022424,K102436,K071370,K142260,K083550,K121131,K033243,K024111,K143051
    Why did this record match?
    Reference Devices :

    K022424, K102436, K071370, K142260, K083550, K121131, K033243, K024111

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

    ArgenIS Titanium Abutments are intended to be single use available by prescription only in the construction of dental restorations supported by the endosseous dental implant. The ArgenIs Titanium Abutments are designed to specifically fit an individual patient's needs of the final restoration. All digitally designed abutments files are intended to be sent to Argen manufacturer for milling. The ArgenIS Titanium Abutments are compatible with the following implant systems:

    | IMPLANT BRAND
    NAME | PLATFORM | Manufacturer | Implant Trade
    Name | Implant
    Line/Connection | Implant
    Diameter |
    |---------------------------------|-----------|--------------------------|---------------------------------------------------|--------------------------------------------------------------|------------------------------|
    | Nobel Biocare Replace
    Select | 6.0mm | Nobel Biocare USA | Nobel Replace
    Tapered
    Conical
    Connection | Nobel Replace
    Internal Conical
    Connection WP | 6.0mm |
    | Nobel Biocare Active | 3.5mm | Nobel Biocare AB | NobelActive
    Internal
    Connection
    Implant | Nobel Active
    Internal Conn.
    RP and NP | 3.0, 3.5, 4.3,
    5.0mm |
    | Nobel Biocare Active | 4.3/5.0mm | Nobel Biocare AB | NobelActive
    Internal
    Connection
    Implant | Nobel Active
    Internal Conn.
    RP and NP | 3.0, 3.5, 4.3,
    5.0mm |
    | Straumann Bone Level | 3.3mm | Straumann USA | Straumann
    Bone Level
    Tapered
    Implants | Bone Level
    Internal Conn.
    NC | 3.3mm |
    | Straumann Bone Level | 4.1/4.8mm | Straumann USA | Straumann
    Bone Level
    Tapered
    Implants | Bone Level
    Internal Conn.
    RC | 4.1, 4.8mm |
    | Straumann Synocta | 4.8mm | Institut Straumann
    AG | Straumann
    Dental Implant | Synocta Implant
    Internal Conn.
    4.8mm RN (Reg.
    Neck) | 4.8, 6.5mm |
    | Straumann Synocta | 6.5mm | Institut Straumann
    AG | Straumann
    Dental Implant | Synocta Implant
    Internal Conn.
    6.5mm (Wide
    Neck) | 4.8, 6.5mm |
    | Astra Tech OsseoSpeed | 3.5/4.0mm | Astra Tech AB | AstraTech
    Implant
    OsseoSpeed | OsseoSpeed
    Internal Conical
    Connection RP | 3.6, 4.2, 4.8mm |
    | Astra Tech OsseoSpeed | 4.5/5.0mm | Astra Tech AB | AstraTech
    Implant
    OsseoSpeed
    Plus | OsseoSpeed Plus
    Internal Conical
    Connection RP | 3.0, 3.5, 4.0, 4.5,
    5.0mm |

    Device Description

    Argen IS Titanium Abutments are designed specifically for an Individual patient and then milled from a Titanium blank with a pre-milled interface correlating to a specific implant system. This abutment can be fixed in the laboratory model work containing the implant analog for final construction of the related prosthetic restoration. The Argen IS Titanium Abutments are then intended to be fixed in the mouth with the included prosthetic screw. The Argen IS Titanium Abutments are supplied with 2 screws (1) A Final Screw for fixing to the endosseuos Implant. (2) A lab screw for Laboratory use during construction of related restoration to avoid any damage to the final prosthetic screw will be marked "final Screw". The final screw must be torqued on the endosseuos Implant with the specific torque setting provided. The device is finalized at the Argen facility and provided to the dental laboratory in a final patient specific form.

    Minimum and Maximum Gingival Height is 0-6mm

    Minimum diameter at abutment/implant interface is 3.5mm to interface base

    Maximum length of abutment from abutment/implant interface is 12.5mm

    Minimum length of abutment post (length above the abutment collar/gingival height) is 4.0mm.

    Minimum wall thickness at abutment/implant interface is 0.65mm

    Maximal angle in relationship to the long axis of implant is 30°

    The available range of diameters and connection type is summarized on the table below:

    AI/ML Overview

    This document describes a 510(k) premarket notification for the "ArgenIS Titanium Abutments" by Argen Corporation. This type of regulatory submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a clinical study or performance goals with clinical outcomes. Therefore, much of the requested information (like expert ground truth, adjudication methods, MRMC studies, training set details, or effect size of human readers with AI assistance) is not applicable to this type of device and submission.

    Here's an analysis of the provided text in relation to your request, highlighting what can and cannot be extracted:

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

    The document does not explicitly state "acceptance criteria" in the format of a clinical trial or performance study with numerical targets and achieved results. Instead, it demonstrates substantial equivalence by comparing the device's technical characteristics and performance to predicate devices. The "performance" in this context refers to bench testing to ensure functional compatibility and mechanical integrity, not clinical outcomes.

    FeatureAcceptance Criteria (Implied / Predicate Comparison)Reported Device Performance
    MaterialPredicate devices use Titanium-6AL-4 Vanadium ELI Alloy or CP Titanium.ArgenIS Titanium Abutments use Titanium-6AL-4 Vanadium ELI Alloy. (Consistent with predicate K143051 and functionally equivalent to CP Titanium for this application).
    Intended UseSimilar to predicate devices: construction of dental restorations supported by endosseous dental implants, single use, prescription only, designed to fit individual patient needs.ArgenIS Titanium Abutments share the same intended use: single-use, prescription-only for dental restorations supported by endosseous dental implants, designed for individual patient needs. "Minor changes in descriptive terms used in the indications for use do not change the intended use of the proposed device."
    Prosthetic ConnectionCompatibility with specific implant systems (Nobel Biocare, Straumann, Astra Tech) as listed for predicate devices and the new device.ArgenIS Titanium Abutments are compatible with a range of Nobel Biocare, Straumann, and Astra Tech implant systems, similar to the scope covered by the various predicate devices.
    Implant Diameters/LengthsWithin the range of existing predicate devices.ArgenIS supports diameters 3.3mm, 3.5mm, 4.0mm, 4.1mm, 4.3mm, 4.5mm, 4.8mm, 6.0mm, 6.5mm, which are covered by the collective range of the predicate devices.
    Type of RetentionScrew-retained to the implant; prosthesis cement-retained to the abutment, consistent with predicate devices.ArgenIS Titanium Abutments are screw-retained to the implant, with the prosthesis cement-retained to the abutment. (Identical to all predicates shown).
    Manufacturing ProcessMachining, consistent with predicate devices.ArgenIS Titanium Abutments are manufactured via machining. (Identical to all predicates shown).
    Abutment SterilizationMoist Heat (Steam), consistent with predicate devices.ArgenIS Titanium Abutments use Moist Heat (Steam) for sterilization. (Identical to all predicates shown).
    Abutment AngulationWithin the range of predicate devices (0°-30°).ArgenIS Titanium Abutments have an angulation range of 0° - 30°. (Consistent with primary predicate K143051, and overlaps with/encompasses other predicates' ranges).
    Dimensional CompatibilityDemonstrated through tolerance analysis and functional fit checks."Testing included tolerance analysis to ensure abutment/implant interface compatibility. Functional fit checks of abutment blank to compatible implant and prosthetic screw. Testing showed correct functionality of the device as per its intended use, including dimensional compatibility, and mechanical performance."
    Mechanical Performance (Fatigue)Conformance to ISO 14801 for worst-case scenarios (smallest diameter, shortest length from each platform). This implicitly means meeting at least the performance levels of predicate devices that would also conform to ISO 14801."Fatigue testing was conducted on worst case scenario samples. Worst case scenario was defined as the smallest diameter and shortest length from each platform. The worst case scenarios from each of the proposed platforms were tested per ISO 14801." (The document asserts conformance to performance specifications, implying successful completion of these tests in line with relevant standards and predicate performance).

    2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Sample Size: The document mentions "worst case scenario samples" for fatigue testing but does not specify the exact number of samples. This is typical for bench testing where the focus is often on specific critical configurations rather than a large statistical sample of all possible configurations.
    • Data Provenance: This was "Non-clinical test data" from "Bench testing." As such, there is no country of origin for patients or retrospective/prospective classification. It's laboratory data.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    Not applicable. This device is an implant abutment, and the testing involved engineering/mechanical validation (bench testing), not clinical diagnosis or interpretation requiring expert human judgment for ground truth.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    Not applicable. There was no human expert adjudication of test results in the clinical sense. Performance was determined by objective measurements during bench testing against engineering specifications and standards.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    Not applicable. This device is a dental implant abutment, not an AI diagnostic tool.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    Not applicable. This device is a physical medical device, not an algorithm.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    The "ground truth" for this device's performance is based on engineering specifications, material properties, and relevant international standards (e.g., ISO 14801). For compatibility and fit, it's about precise dimensional measurements and physical mating tests against the actual or specified dimensions of compatible implant systems.

    8. The sample size for the training set

    Not applicable. This is a physical medical device, not an AI model.

    9. How the ground truth for the training set was established

    Not applicable. This is a physical medical device.

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