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    K Number
    K183138
    Device Name
    Certain BellaTek Express and BellaTek Flex Abutments
    Manufacturer
    Biomet 3i
    Date Cleared
    2019-07-02

    (231 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K170588,K072642
    Why did this record match?
    Device Name :

    Certain BellaTek Express and BellaTek Flex Abutments

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

    Certain BellaTek® Express and BellaTek® Flex Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained.

    All digitally designed superstructures and/or hybrid abutment crowns for use with Certain BellaTek Express or BellaTek Flex Abutments are intended to be sent to a Biomet 3i validated milling center for manufacture.

    Device Description

    The Certain BellaTek Express Abutment and BellaTek Flex Abutment (subject devices) are Titanium-base type abutments to be used as the apical part of two-piece abutments. The coronal part of the two-piece abutment is a CAD/CAM designed and manufactured superstructure. All digitally designed superstructures manufactured in zirconia conform to ISO 13356:2015 and ISO 6872:2015. Biomet 3i recommends the use of Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436) to affix the zirconia superstructure and/or hybrid abutment crown to the Certain BellaTek Express and BellaTek Flex abutments. Certain BellaTek Express Abutment and BellaTek Flex Abutment are intended to be used with Biomet 3i Certain (Internal Hex) dental implants for single and multi-unit restorations. The subject device abutments are available in hexed (single-unit) and nonhexed (multi-unit) configurations. They are available in pre-defined platform diameters, emergence profiles and heights to accommodate varying patient anatomies. They are machined from Titanium Alloy. They are intended for single use only. The device is packaged in a sealed nylon bag and sold non-sterile.

    AI/ML Overview

    This document pertains to the 510(k) premarket notification for Certain BellaTek® Express and BellaTek® Flex Abutments, K183138. It describes dental implant abutments and does NOT describe an AI/ML medical device. Therefore, the information requested regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device cannot be extracted from this document.

    The document discusses substantial equivalence to predicate devices based on:

    • Intended Use: Similar, supporting prosthetic devices in edentulous patients.
    • Operating Principle: Attaching to dental implants to restore chewing function.
    • Identical Materials: Titanium Alloy (Ti-6Al-4V ELI) and Zirconia for abutments.
    • Similar Fundamental Design: Including platform diameters, screw or cement retention options.

    Performance Data (Non-clinical):

    • Sterilization Validation: Per FDA Guidance and ISO 17665-1 and ISO 17665-2, demonstrating a sterility assurance level (SAL) of 10^-6.
    • Biological Evaluation: In accordance with FDA Guidance and ISO 10993-1, demonstrating acceptable biocompatibility.
    • MR Testing Data: Leveraged, and the device is labeled as MR conditional.
    • Design & Development: In accordance with FDA Guidance Document for Root-form Endosseous Dental Implants and Abutments.

    No clinical data was included in this submission.

    Therefore, I cannot provide the information requested in the format of an AI/ML device acceptance criteria and study.

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