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510(k) Data Aggregation

    K Number
    K250763
    Device Name
    Reon
    Manufacturer
    C.E.I.B.med
    Date Cleared
    2025-05-12

    (60 days)

    Product Code
    EBF, EBG
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    C.E.I.B.med

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Reon is a 3D printing resin used in dentistry for the fabrication of both temporary and permanent dental restorations, specifically crowns, bridges, inlays, onlays, and veneers.
    Device Description
    Reon is a photopolymerizable, methacrylate-based composite resin used in dental CAD/CAM technology for the fabrication of dental prostheses. This resin is specifically designed for both temporary and permanent dental restorations, such as crowns, bridges, inlays, onlays, and veneers, utilizing 3D printing processes. Reon is a light-curing methacrylate-based polymer resin used in the production of dental restorations through CAD/CAM technology at dental clinics. This resin is suitable for the 3D printing process of temporary and permanent dental restorations, especially crowns, bridges, inlays, onlays, and veneers. Reon is made from a methacrylate-based resin and is stored in liquid form in Aluminum 1050A or 1070A bottles, with two different volumes (500 g/1,000 g) for each shade. To support a variety of shades, it offers four different options: Clear, A1, A2 and A3. This resin is cured using a UV (ultraviolet) laser with a wavelength of 405nm, activated by a specific photoinitiator at 405nm. Reon is suitable for creating custom dental restorations using UV-curing 3D printers. It can be used under the following printing and curing conditions: - Layer Thickness: 50 μm - Resolution: X, Y axis resolution of 40-90 μm - Printing Process: Compatible with DLP (Digital Light Processing) based 3D printers - Post-Curing: Final polymerization is completed by additional UV curing after printing Reon is compatible with UV-curing 3D printers and is primarily used with the following devices: - 3D Printer: DLP-based 3D printers - Software: CAD files (.stl) generated from dental software for printing - Scanner Compatibility: Intraoral Scanner and 3D design software (e.g., 3Shape) The clinical workflow for Reon is as follows: 1. The dentist uses an intraoral scanner to scan the patient's mouth and create a CAD file. 2. Based on the scan data, the restoration is designed using software. 3. The designed STL file is used to print custom crowns, bridges, etc., with a 3D printer. 4. The printed restoration undergoes additional UV curing in a post-curing device to complete the hardening process. 5. The final restoration is then trimmed and polished to fit the patient's teeth before being provided to the patient. Reon has passed biocompatibility testing and meets the necessary physical, chemical, and mechanical properties, making it suitable for use in dental restorations. Please note that this product must be used in conjunction with a scanner, design software, and a 3D printer, which are not included with the product. Additionally, to achieve optimal performance, the UV curing process after printing is essential.
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