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510(k) Data Aggregation

    K Number
    K121843
    Device Name
    NP-CAST ABUTMENT SYSTEM
    Manufacturer
    OSSTEM IMPLANT CO.,LTD
    Date Cleared
    2012-12-11

    (169 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K112045,K110308,K081575
    Why did this record match?
    Device Name :

    NP-CAST ABUTMENT SYSTEM

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

    NP-Cast Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

    Device Description

    NP-Cast Abutment System is used for prosthetic restoration. It is used for cases with path and aesthetic and spatial constraints. After customization, be sure to use only dental nonprecious metal (Co-Cr-Mo alloy) for casting to make the prosthesis When cast a prosthesis with NP-Cast Abutment System, Post height above the transmucosal collar of NP-Cast Abutment System has to be taller than 4mm and Maxmimum angulation has to be less than 30°. The NP-Cast Abutment System consists of Abutment and Abutment Screws.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a medical device (NP-Cast Abutment System), not a study report detailing performance against acceptance criteria for an AI/ML diagnostic or predictive device. Therefore, much of the requested information (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable or available in this document.

    However, I can extract information related to the device's non-clinical testing which serves as the "study" for this type of device and the "acceptance criteria" through comparison with predicate devices.

    1. Acceptance Criteria and Reported Device Performance

    For this type of device (a dental abutment), "acceptance criteria" are primarily established by demonstrating substantial equivalence to legally marketed predicate devices and meeting relevant performance standards, particularly mechanical safety. The document focuses on showing that the NP-Cast Abutment System is equivalent in material, indication for use, design, and technological characteristics to its predicates.

    Acceptance Criteria CategorySpecific Acceptance Criteria (Inferred)Reported Device Performance
    Substantial EquivalenceThe device should be similar to predicates in intended use, technology, claims, material composition, and performance characteristics.The NP-Cast Abutment System is "substantially equivalent in design, function and intended use" to the SimpleLine II Abutment System (K112045) and two OSSTEM Prosthetic Systems (K110308, K081575). The materials (Co-Cr-Mo Alloy) and intended use are identical or highly similar to predicates.
    BiocompatibilityThe device's materials must be biocompatible for their intended use within the human body."Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable international and US regulations." (Specific results not detailed, but conformance is stated).
    Mechanical Fatigue StrengthThe device must withstand expected physiological loading conditions without fracture or failure, as evaluated by relevant testing standards (e.g., "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment"). Specific acceptance limits would be defined by the standard and comparison to predicate performance for "worst-case scenario." Post height above transmucosal collar > 4mm and maximum angulation 4mm and maximum angulation
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