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510(k) Data Aggregation

    K Number
    K062936
    Manufacturer
    Date Cleared
    2006-12-19

    (82 days)

    Product Code
    Regulation Number
    872.3640
    Panel
    Dental
    Reference & Predicate Devices
    Predicate For
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Nobel Biocare's NobelPerfect Conical Connection implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelPerfect Conical Connection implants are indicated for single or multiple unit restorations. The NobelPerfect Conical Connection implants can be used in splinted or non-splinted applications. The NobelPerfect Tapered Conical Connection implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

    Device Description

    Nobel Biocare's NobelPerfect Conical Connection implants are threaded, root-form dental implants intered for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients.

    The NobelPerfect Conical Connection implants are similar in design to the NobelPerfect Groovy implants cleared under "Groovy Implants" (K050258). Like the NobelPerfect Groovy implant, the NobelPerfect Conical Connection implant is machined from commercially pure titanium, grade 4, have a tapered body Onlival Onlinedian implant is machines nother the body, and a TiUnite "sufface treatment. The difference between the two implants is that the NobelPerfect Conical Connection implants have the same internal conical connection as the SFB implants, cleared under "SFB & CFB Implants"(K061003).

    AI/ML Overview

    This document is related to a 510(k) premarket notification for a dental implant, the NobelPerfect Conical Connection. It describes the device, its indications for use, and a letter from the FDA stating its substantial equivalence to predicate devices.

    The document does not contain information about acceptance criteria, device performance testing, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment. This type of information is typically found in engineering reports, clinical study summaries, or validation reports, which are usually separate from the 510(k) summary and FDA clearance letter provided here.

    Therefore, I cannot provide the requested table and details based on the given input.

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