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510(k) Data Aggregation

    K Number
    K251283
    Device Name
    Once-Fil Flow
    Manufacturer
    Mediclus Co., Ltd.
    Date Cleared
    2025-06-06

    (42 days)

    Product Code
    EBF
    Regulation Number
    872.3690
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Temporary inlay and onlay treatments of the cavity. - Sealing of openings for implant screws. - Relining material for temporary crowns and bridges. - Covering of the gingival margin - Fixing of resin matrix during filling placement. - Block-out material for retentive ares in the dental arch, e.g. before taking impressions.
    Device Description
    Once-Fil Flow is a light-curing filling material designed for temporary restorations. It serves as an interim solution before the placement of a final prosthesis, providing functions such as pulp protection and maintaining tooth position. The material is suitable for temporary fillings in prepared cavities and inlay/onlay cases. To accommodate different clinical needs, Once-Fil Flow is available in two shades. The Yellow shade is ideal for anterior teeth, where esthetics are a priority, while the Blue shade provides clear visual contrast, making it easier to identify and remove before permanent restoration. The application process involves preparing the tooth surface, applying an appropriate amount of material, and light-curing it. Once cured, the material can be finished and polished using conventional instruments.
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    K Number
    K250317
    Device Name
    EsFlow PLUS
    Manufacturer
    Spident CO. LTD
    Date Cleared
    2025-05-30

    (115 days)

    Product Code
    EBF
    Regulation Number
    872.3690
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Direct restorations - Base and Liner - Block out undercut - Repair of (in)direct aesthetic restorations - Core build-up
    Device Description
    EsFlow PLUS is a light-cured radiopaque flowable composite resin used for direct restoration. It has a smooth surface, so it is applied smoothly to the teeth, and has good gloss and aesthetics. In addition, it has high mechanical strength, so it can sufficiently withstand the occlusal force. EsFlow PLUS has two types of viscosities, so it can be applied to various clinical cases. The inorganic filler of EsFlow PLUS has a particle size range of 0.01 to 0.5 μm, and a volume ratio of about 42 to 47% depending on the model.
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    K Number
    K251578
    Device Name
    BEAUTIFIL II
    Manufacturer
    Shofu Dental Corporation
    Date Cleared
    2025-05-27

    (5 days)

    Product Code
    EBF
    Regulation Number
    872.3690
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Anterior and posterior restorations - Repair of restorations and prostheses - Core-build up - Direct laminate veneer
    Device Description
    Not Found
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    K Number
    K250778
    Device Name
    Sil-Flow
    Manufacturer
    DSI Dental Solutions Ltd
    Date Cleared
    2025-05-23

    (70 days)

    Product Code
    EBF
    Regulation Number
    872.3690
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sil-Flow is indicated for [A] Temporary inlay and onlay treatments of the cavity [B] Sealing of openings for implant screws [C] Relining material for temporary crowns and bridges [D] Block-out material for retentive areas in the dental arch, e.g. before taking impressions [E] Covering of the gingival margin [F] Fixing of resin matrix during filling placement [G] Temporary filling of cavities
    Device Description
    Sil-Flow is a flowable light-cured temporary filling material used for filling and sealing.
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    K Number
    K251239
    Device Name
    GrandioSO Unlimited
    Manufacturer
    VOCO GmbH
    Date Cleared
    2025-05-21

    (29 days)

    Product Code
    EBF
    Regulation Number
    872.3690
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - class I to V restorations - reconstruction of traumatically damaged anteriors - facetting of discolored anteriors - correction of shape and shade for improved aesthetic appearance - locking, splinting of loose teeth - repairing veneers - restoration of deciduous teeth - core-build-up under crowns - composite inlays
    Device Description
    Not Found
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    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
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    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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    K Number
    K250497
    Device Name
    Additive Manufacturing (Light Curing) Crown Bridge Resin
    Manufacturer
    Aidite (Qinhuangdao) Technology Co., Ltd
    Date Cleared
    2025-04-30

    (69 days)

    Product Code
    EBF, EBG, POW, PZY
    Regulation Number
    872.3690
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Additive Manufacturing (Light Curing) Crown Bridge Resin is a light-cured resin indicated for the fabrication of permanent single crowns in the anterior and posterior region, denture teeth, inlays, onlays, veneers and implant crown. It is also used for long-term provisional crowns and bridges.
    Device Description
    Additive Manufacturing (Light Curing) Crown Bridge Resin is a light-curing, hybrid dental material, composed of methacrylic acid esters, inorganic filler, photoinitiator, organic pigments, inorganic pigments and additives. It is Liquid resin for dental 3D printing of permanent single crowns in the anterior and posterior region, denture teeth, inlays, onlays, veneers and implant crown. It is also used for long-term provisional crowns and bridges. The Subject device is used by a dentist or dental technician for the CAD/CAM manufacturing of temporary or permanent dental restorations. For use in Digital Light Processing (DLP)- 3D printers utilizing wavelengths at 385nm or 405nm. The Subject device is packaged in black plastic bottles made of high density polyethylene (HDPE) according to the weight of the resin liquid. There are different shades A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, BL1, BL2, BL3, BL4, and the different shades are reflected in the different colors of finished restorations.
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    K Number
    K250823
    Device Name
    Any-Com Flow
    Manufacturer
    Mediclus Co., Ltd.
    Date Cleared
    2025-04-14

    (27 days)

    Product Code
    EBF
    Regulation Number
    872.3690
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Anterior and posterior restorations. - Indirect restorations for Inlays, onlays and veneers.
    Device Description
    Any-Com Flow is a composite resin material designed for use in anterior and posterior restorations. It is composed of an enhanced zirconia filler, and all shades of the material are radiopaque. It is conveniently packaged in a syringe with a wide caliber. Dentists can dispense the material using their own instruments and apply it to the tooth. The product offers a wide range of options with a total of 9 shades available. Dentists can select shades such as A1, A2, B1, B2, etc., based on the desired brightness, yellowness, and darkness that match the patient's natural teeth. After the appropriate tooth pretreatment process for the selected shade, Any-Com Flow is applied to the teeth using enclosed tip and in the appropriate amount. Once applied, it is permanently bonded to the tooth structure by using a photopolymerizer owned by the dentist for photocuring.
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    K Number
    K250267
    Device Name
    Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068)
    Manufacturer
    Kettenbach GmbH & Co. KG
    Date Cleared
    2025-03-14

    (43 days)

    Product Code
    EBF
    Regulation Number
    872.3690
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Visalys® Bulk Fill: Loss of tooth substance due to caries, dental wear or developmental disorders. Techniques: Class I and II restorations, non-tunneled class III restorations, filling in deciduous teeth, core buildups, cavity floor elevation, repair of direct restorations after appropriate pretreatment and splinting / locking of teeth. Visalys® Bulk Flow: Loss of tooth substance due to caries, fractures, dental wear or developmental disorders. Techniques: Class I and II restorations, non-tunneled class III restorations, filling in decidious teeth, core build-ups, cavity lining, cavity floor elevation, blocking out undercuts, repair of direct restorations after appropriate pretreatment, extended fissure sealing and splinting / locking of teeth.
    Device Description
    Visalys® Bulk Fill is a light-cured, nano-hybrid filling composite that can be modeled and is available in a universal shade. For adhesive cementation, a dentin-enamel bond is used. The material is available in screw syringes and can be applied in layers up to 4 mm thick. The filling material contains approx. 82% inorganic fillers by weight. The radiopacity is 2.5 mm aluminium*. The color stability meets the requirements of DIN EN ISO 4049. Visalys® Bulk Fill is thus suitable for both posterior teeth and also for fillings without tunnel preparation in the anterior tooth area, particularly class III and V. Visalys® Bulk Flow is a light-cured, flowable nano-hybrid filling composite and is available in a universal shade. For adhesive cementation, a dentin-enamel bond is used. The material is available in syringes and can be applied in layers up to 4 mm thick. The filling material contains approx. 72% inorganic fillers by weight. The radiopacity is 2.0 mm aluminium*. The color stability meets the requirements of DIN EN ISO 4049. Visalys® Bulk Flow is thus suitable for both posterior teeth and also for fillings without tunnel preparation in the anterior tooth area, particularly class III and V. Capping is not necessary.
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    K Number
    K242713
    Device Name
    Any-Com Bulk
    Manufacturer
    MEDICLUS CO., LTD.
    Date Cleared
    2025-02-07

    (151 days)

    Product Code
    EBF
    Regulation Number
    872.3690
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Base under Class I and Class II direct restorations - Liner under direct restorative materials - Restoration of small cavities - Class III and V restorations - Core build-ups
    Device Description
    Any-Com Bulk is a light cured. radiopaque, flowable restorative material for both posterior and anterior restorations. It is designed to be used as a base-liner for Class I and II restorations. The product allows a technique in which a cavity up to 4mm in depth can be filled and cured in a single increment. The product offers 5 shades options available. Users can select shades such as A 1, A2, A3, TL and Blue, based on the desired brightness, yellowness, and darkness that match the patient's natural teeth. After the appropriate tooth pretreatment process, fill the appropriate amount of product to applying area. Once light cured, the composite can be finished and polished using conventional finishing and polishing instruments.
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