BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Primeprint Direct Aligner

    K Number: K250739 · Decision Nov 7, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    143
    Applicant Total
    6
    Review Days
    241

    Basic Information

    Device Name
    Primeprint Direct Aligner
    K Number
    K250739
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5470
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dreve Dentamid GmbH
    Date Received
    March 11, 2025
    Decision Date
    November 7, 2025
    Product Code
    NXC
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NXC Aligner, Sequential

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NXC), ordered by most recent decision date.

    Smylio Aligners

    FDA 510(k)
    FDA Class 2 ·Dental

    SureSmile Aligner (ASSY500020)

    FDA 510(k)
    FDA Class 2 ·Dental

    ZSmile System

    FDA 510(k)
    FDA Class 2 ·Dental

    Clear Aligner (SCF-3348)

    FDA 510(k)
    FDA Class 2 ·Dental

    Invisalign® Palatal Expander System

    FDA 510(k)
    FDA Class 2 ·Dental

    Invisalign Specifix Attachment System

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by Dreve Dentamid GmbH

    K Number Device Name
    K200580 FotoDent denture
    K190571 StoneBite and StoneBite scan
    K171562 Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono
    K162408 Nano Varnish, Plaquit, Lightpaint on Surface
    K171729 Fixtemp C&B