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510(k) Data Aggregation

    K Number
    K242929
    Device Name
    Fas Aligner System
    Manufacturer
    Xplora 3D Europe S.L
    Date Cleared
    2024-12-20

    (87 days)

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

    Xplora 3D Europe S.L

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fas Aligner System is intended for the orthodontic treatment of malocclusion.
    Device Description
    Fas Aligner System consist of a series of customized removable plastic orthodontic appliances which sequentially reposition teeth by way of continuous gentle force. This removable plastic orthodontic aligners intended as an alternative to conventional wire and bracket technology. Fas Aligner System are designed based on traditional mold impression or digital scans of the patient's dentition submitted by a dental health professional (e.g., a dentist or orthodontist). Fas Aligner System 's staff in the Prescription and Planning area create the virtual planning including the attachments, as well as the movements they consider necessary to achieve the intended tooth correction. For this process the following previously released software Nemocast (K232549). The 3D specialists use the planned data to produce the complete product design. The responsible of the Planning/Prescription department reviews the design to verify that it has been done as required and, if necessary, proposes changes. Once the design has been approved by the clinician, the next phase of printing and preparation of models is carried out. This phase takes place in the Printer Room and is carried out by 3D Printing Technicians. For the entire manufacturing process, the models are identified with the clinical case number. The thermoforming equipment is used for the manufacturing process of the aligners. The printed model is placed on the platform and the thermoforming sheet is placed, which is made with material previously released by means of the K200125 (Erkodur). Once the printed thermoforming sheet is obtained, the contour of the thermoforming sheet is cut out, eliminating the edges. The gingival margins are trimmed. The product is not sent sterile, it is cleaned to remove all residues that may have remained from the manufacturing process. The product, the splint, is placed in labeled bags. The aligners are sent back to the dentist for distribution to the patient in sequential stages and that the dentist checks the aligners for fit and function and monitors the treatment from the first aligner until treatment is completed.
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