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510(k) Data Aggregation

    K Number
    K250739

    Validate with FDA (Live)

    Device Name
    Primeprint Direct Aligner
    Manufacturer
    Dreve Dentamid GmbH
    Date Cleared
    2025-11-07

    (241 days)

    Product Code
    NXC
    Regulation Number
    872.5470
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K232448,K212680
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Primeprint Aligner is a light curing resin intended for the treatment of tooth malocclusion in patients with developed permanent dentition. Primeprint Aligner repositions teeth by way of continuous gentle force.

    Intended place of use: Orthodontic/dental practices/clinics, dental laboratories

    Device Description

    Primeprint Direct Aligner is a light-curing material for the production of aligners using the Primeprint Solution (Primeprint 385nm DLP 3D printer and Primeprint Post Processing Unit). The material is intended for the treatment of tooth malocclusion in patients with developed permanent detention. Primeprint Direct Aligner repositions teeth by way of continuous gentle force.

    AI/ML Overview

    N/A

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