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510(k) Data Aggregation

    K Number
    K232560
    Device Name
    Angled Abutment
    Manufacturer
    Arum Dentistry Co., Ltd.
    Date Cleared
    2023-12-19

    (118 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K213506,K230725,K182091
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crown, bridges, or over-dentures.

    Device Description

    The Angled Abutment is made from Ti-6Al-4V Eli (conforming to ASTM F136). Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crown, bridges, or over-dentures. The Angled Abutment has two types of connection (HEX and Non-HEX). The Angled Abutment connections compatible with NB 1 SA Implant System and NB Implant System. The Angled Abutment surfaces are partially TiN coated. Angled Abutments are supplied with an abutment screw previous cleared device as K213506.

    The dimension ranges of the subject device are below:

    No.Device NameDimension
    1Angled AbutmentØ 4.5, 5.5 (D) x 8 mm (Post Height) x 17°
    2Abutment Screw (Cleared in K213506)Ø 2.35 (D) x 8.4 mm (L)

    Angled Abutment and Abutment Screw (Cleared in K213506) are provided non-sterile. The abutment should be sterilized before use by end user sterilization. These devices are intended for single use only.

    The Angled Abutment is compatible with the following implant systems.

    Manufacturer510(k) No.Implant system compatibilityDimension
    ARUM DENTISTRY Co., Ltd.K213506NB 1 SA Implant SystemØ 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5
    ARUM DENTISTRY Co., Ltd.K230725NB Implant SystemØ 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5
    AI/ML Overview

    The provided text is an FDA 510(k) summary for a dental device called an "Angled Abutment." It does not contain any information about an AI/ML powered device, a study involving human readers, or any other data that would allow for the detailed description requested in the prompt regarding acceptance criteria and a study to prove performance for an AI/ML product.

    The document primarily focuses on demonstrating the substantial equivalence of the "Angled Abutment" to previously cleared predicate devices based on its materials, design, intended use, and mechanical performance testing (specifically static and fatigue testing according to ISO 14801).

    Therefore, I cannot fulfill your request for information related to:

    • A table of acceptance criteria and reported device performance for an AI/ML device.
    • Sample size and data provenance for an AI/ML test set.
    • Number and qualifications of experts for ground truth establishment.
    • Adjudication methods for a test set.
    • MRMC comparative effectiveness study or effect size.
    • Standalone (algorithm-only) performance.
    • Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
    • Sample size for training set or how its ground truth was established for an AI/ML device.

    The document is solely about a physical dental implant component and its mechanical and material properties. The 'Performance Data' section only mentions biocompatibility, sterilization validation, mechanical performance testing (ISO 14801), and MR environment condition assessment – none of which involve AI/ML.

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