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510(k) Data Aggregation

    K Number
    K233935
    Device Name
    DigiLine Direct Print Aligner System
    Date Cleared
    2024-04-05

    (113 days)

    Product Code
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Park Dental Research Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DigiLine Direct Print Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The DigiLine Direct Print Aligner System repositions teeth by way of continuous gentle force.
    Device Description
    The Proposed Device, DigiLine Direct Print Aligner System consists of multiple stages of 3D printed plastic aligners designed to be worn in sequence to facilitate the movement of a patient's teeth to the final desired treatment position. The sequential stages of aligners introduce incremental movements that move teeth by way of gentle continuous force to achieve a more optimal bite profile. The aligners are to be worn 20 to 22 hours a day and are to be removed for eating and for cleaning. The Proposed Device is designed from digital scans of a patient's dentition submitted by a dental health professional (e.g. dentist or orthodontist). Using the scan, sequential stages of dental models are designed and approved by a physician prior to physical manufacturing. Once the treatment plan is reviewed and approved by a dental health professional, each aligner stage is fabricated by additive manufacturing, specifically 3D printing. The 3D printed aligner then undergoes post-processing and cleaning prior to packaging for patient use. DigiLine Direct Print Aligner System are direct-printed using DigiLine Direct Print Resin. DigiLine Direct Print Resin is a light-cured, methacrylate-based resin. Methacrylate-based resins are commonly used for the production of dental structures.
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    K Number
    K180648
    Device Name
    Park Dental Research Aligners
    Date Cleared
    2019-01-08

    (301 days)

    Product Code
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Park Dental Research Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Park Dental Research Aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Park Dental Research Aligners positions teeth by way of continuous gentle force.
    Device Description
    The Park Dental Research Aligners device is fabricated of clear thin thermoformed polyurethane plastic in a sequential series to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.
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    K Number
    K181220
    Device Name
    Juell 3D Volo Base
    Date Cleared
    2018-10-12

    (158 days)

    Product Code
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    Park Dental Research Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Juell 3D Volo Base is a light-cured resin indicated for the fabrication of denture bases fabricated in dental laboratories, including full and partial removable dentures. The material is an alternative to traditional heat cured and auto polymerization resins. Juell 3D Volo Base is intended exclusively for professional dental work. Fabrication of denture bases with Juell 3D Volo Base requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer and post-cure unit.
    Device Description
    Juell 3D Volo Base 3D-printing material is a light-cured resin indicated for the manufacturing of denture bases. The material is used in a 3D printer, which prints the shape determined by a 3D stereolithographic drawing. After printed product is placed in a UV-light curing box for final polymerization. 3D printer is not included with the device.
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