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510(k) Data Aggregation

    K Number
    K253959

    Validate with FDA (Live)

    Device Name
    Primevision 3D
    Manufacturer
    Dentsply Sirona
    Date Cleared
    2026-02-05

    (57 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology
    Age Range
    0 - 21
    Reference & Predicate Devices
    K230985,K181576,K181136,K160506,K230505,K201140
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The X-ray system creates data for digital exposures in the maxillofacial area and in sub-areas for dentistry and pediatric dentistry and for hard tissue diagnostics within ENT medicine.

    Device Description

    Primevision 3D is a digital panoramic and cone beam computed tomography (CBCT) x-ray device. A Computed tomography x-ray system (21 CFR 892.1750) is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. The subject Primevision 3D uses just one imaging detector to collect data for both 2D and 3D modes of operation. Additionally, the Primevision 3D does not offer a cephalometric mode.

    AI/ML Overview

    N/A

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