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    K Number
    K182293
    Device Name
    OsseOne Dental Implant System
    Manufacturer
    Synoross DBA OsseOne
    Date Cleared
    2019-02-15

    (175 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K083324,K090709,K170372
    Why did this record match?
    Reference Devices :

    K083324, K090709

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

    OsseOne Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients and chewing function. Osse one implants are intended for single or multiple unit restorations on splinted applications. OsseoPlus and OsseoLock are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. OsseoLock 3.3 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.3 implants adjacent to one another.

    Device Description

    OsseOne Dental Implant System is an internal hex implant system with two models of implant, OsseoLock which is a cylindrical implant and OsseoPlus which is a spiral implant. OsseoLock comes in 3.3, 3.7, 4.2, 5.0, and 6.0 diameter. OsseoPlus comes in diameters of 3.5, 3.75, 4.2, 5.0 and 6.0. The implants come in lengths of 8, 10, 11.5, 13 and 16. OsseoLock 5.0 and 6.0 diameter implants do not come in 16mm length. Both straight and angled abutments are available. The implants have a grit blasted and acid etched surface. Standard abutments, standard narrow abutments, standard shoulder abutments, standard wide shoulder abutments, multi-unit abutments, denture lock abutments, overdenture abutments, angled overdenture abutments, ball attachments, healing caps (3.8, 4.6, 5.5, and 6.3 mm diameter), UCLA in 4.5mm diameter and standard 15° and 25° abutments are included in the system.

    AI/ML Overview

    The provided text describes the OsseOne Dental Implant System and its equivalence to a predicate device, the SpiralTech Dental Implant System. It does not contain information about an AI/ML-driven device or study parameters related to AI/ML device performance. Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device.

    The document discusses the following types of testing for the OsseOne Dental Implant System:

    • Dynamic fatigue testing (ISO 14801): To determine abutment strength.
    • Surface analysis: According to FDA guidance.
    • Sterilization validation: For implants (ISO 11137-1 and ISO 11137-2) and abutments (ISO 17665-1 and ISO 17665-2).
    • Package integrity testing and accelerated aging: According to ASTM F1929-12, ASTM F 1980-07(2011), ASTM D 4332-13, ASTM D 999-08, ASTM D4169-09, ASTM D5276-98(2009), and ASTM F 3039-13.
    • Materials testing: ASTM F136.
    • Endotoxin testing: USP 161.
    • Cytotoxicity testing: ISO 10993-5.

    The study presented is a substantial equivalence comparison study where the OsseOne Dental Implant System is compared to the SpiralTech Dental Implant System.

    Acceptance Criteria and Reported Device Performance (Table):

    Acceptance Criterion (Implicit from comparison)Reported Device Performance (OsseOne Dental Implant System)
    Indications for Use: Identical to predicate device.Identical to SpiralTech Dental Implant System.
    Materials: Same as predicate device.Same materials as SpiralTech Dental Implant System. Meets ASTM F136.
    Design: Similar to predicate device (minor dimensional differences acceptable).Abutment designs are very similar, some practically identical. Minor dimensional changes do not change substantial equivalence.
    Fatigue Performance (ISO 14801): Run out limits comparable/higher than other implant systems.Run out limits for both designs (OsseoLock and OsseoPlus) are the same or higher than other implant systems.
    Cytotoxicity (ISO 10993-5): Non-cytotoxic.Cytotoxicity testing conducted; surfaces are not cytotoxic.
    Sterilization Efficacy (ISO 11137, ISO 17665): Validated.Implants validated by gamma irradiation. Abutment steam sterilization validated.
    Package Integrity & Shelf Life (ASTM standards): Validated.Package integrity testing and accelerated aging conducted.
    Endotoxins (USP 161): Complies.Endotoxin testing conducted.

    Missing Information (as per your request for AI/ML devices):

    The provided text does not contain any of the following details, as the device is not an AI/ML device:

    • Sample size used for the test set and data provenance (e.g. country of origin of the data, retrospective or prospective)
    • Number of experts used to establish the ground truth for the test set and the qualifications of those experts
    • Adjudication method (e.g. 2+1, 3+1, none) for the test set
    • If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance
    • If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
    • The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
    • The sample size for the training set
    • How the ground truth for the training set was established
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