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510(k) Data Aggregation

    K Number
    K251271
    Device Name
    TempFIT Temporary Crown and Bridge Resin
    Manufacturer
    Rizhao HuGe Biomaterials Company, Ltd.
    Date Cleared
    2025-06-23

    (60 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Product Code :

    EBG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The product is a self-curing composite for the fabrication of temporary crowns, bridges, inlays, onlays and veneers.
    Device Description
    TempFIT Temporary Crown and Bridge Resin is a self-curing composite for the fabrication of temporary crowns, bridges, inlays, onlays and veneers. The mixing ratio, based on volume, base paste: catalyst paste =1:1 or 10:1. TempFIT Temporary Crown and Bridge Resin is delivered in a bio-cartridge. The curing mechanism between methacrylates is self-curing, which fundamentally belongs to free radical polymerization in reaction principle. Free radical polymerization typically occurs in unsaturated molecules containing double bonds. Both methacrylate resins in TempFIT Temporary Crown and Bridge Resin and silane coupling agents on filler surfaces contain numerous carbon-carbon unsaturated double bonds. When the two-component system is mixed, a redox reaction generates abundant free radicals that initiate the polymerization of these double bonds.
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    K Number
    K243370
    Device Name
    DentaTOOTH
    Manufacturer
    Asiga Pty Ltd
    Date Cleared
    2025-05-05

    (187 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Product Code :

    EBG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Asiga DentaTOOTH is intended exclusively for professional dental work. Asiga DentaTOOTH is a 3D print resin indicated for the manufacturing of 3D printed temporary crowns, bridges, inlays, onlays and veneers.
    Device Description
    DentaTOOTH is a resin material used by dental professionals for the manufacture of temporary dental restorations including temporary crowns, bridges, inlays, onlays and veneers. DentaTOOTH resin is available in six Vita shades A1, A2, A3, B1, B2, B3. DentaTOOTH resins are used with digital light processing (DLP) based 3D printers to produce denture temporary dental restorations. DentaTOOTH resin has been validated for use with the Asiga Max Series and Pro Series printers for the manufacture of temporary dental restorations at 385nm wavelengths. DentaTOOTH is a light-cure methacrylate-based resin with photoinitiator, UV absorber, dispersant and pigments. DentaTOOTH is a Type 2, Class 2 resin per ISO 10477:2020 and Type 1, Class 2, Group 2 resin per ISO 4049:2019. DentaTOOTH has a shelf life of 36 months. The device may be stored in Asiga Max and Pro Series printers for up to 4 weeks with hood closed. DentaTOOTH is compliant to ISO 10477:2020 and ISO 4049:2019 for polymer based crown and veneering materials, and polymer based restorative materials, respectively.
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    K Number
    K243621
    Device Name
    Evoblock, Perléon
    Manufacturer
    Evoden Indústria Comércio Importação e Exportação
    Date Cleared
    2025-04-22

    (151 days)

    Product Code
    EBG, EBI
    Regulation Number
    872.3770
    Why did this record match?
    Product Code :

    EBG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indication for use: - Temporary anterior and posterior crowns; - Implant and abutment supported prosthetics; - Partial, complete and hybrid denture prosthetics (base and teeth).
    Device Description
    Not Found
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    K Number
    K243951
    Device Name
    TEMP MASTER, PMMA-based dental resin
    Manufacturer
    Taiwan Dental Materials CO., LTD.
    Date Cleared
    2025-02-21

    (60 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Product Code :

    EBG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TEMP MASTER, PMMA-based dental resin developed by Taiwan Dental Materials CO., LTD. is a self-cured resin indicated for the fabrication of short-term restorations including temporary inlays, crowns, and bridges, which can protect or restore damaged teeth while permanent restorations are being prepared. It is a traditional auto-cured PMMA-based resin composed of powder and liquid. Polymerization occurs when the powder and liquid are mixed at room temperature.
    Device Description
    TEMP MASTER, PMMA-based dental resin, is a self-curing (cold-cure) material designed to fabricate temporary crowns and bridges. It consists of two components: powder and liquid. Polymerization occurs when the powder and liquid are mixed at room temperature. Classified as a Type 1 (autopolymerizable) acrylic resin according to ISO 10477 standards, TEMP MASTER, PMMA-based dental resin provides reliable performance for temporary restorations.
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    K Number
    K231859
    Device Name
    PrimmaArt
    Manufacturer
    DentsCare LTDA
    Date Cleared
    2024-11-26

    (522 days)

    Product Code
    EBG, POW
    Regulation Number
    872.3770
    Why did this record match?
    Product Code :

    EBG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Fabrication of temporary crowns, bridges, inlays, onlays and veneers; - Fabrication of long-lasting temporary restorations; - Rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal.
    Device Description
    Self-curing composite that is highly efficient for the production of temporary pieces for indirect dental procedures such as inlays, onlays, crowns, veneers and bridges. The product consists of a base paste and a catalyzing paste stored in a cartridge and in a double-body syringe, from where they are automatically dispensed in the correct proportion (1:1), providing practical clinical procedures with reduced chances of errors or incorporated bubbles.
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    K Number
    K242559
    Device Name
    Digital Temp
    Manufacturer
    SprintRay Inc.
    Date Cleared
    2024-11-26

    (90 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Product Code :

    EBG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SprintRay Digital Temp is a light-curable resin indicated for the fabrication of individual and fixed temporary full single crowns, temporary partial crowns, and temporary bridges. The material is an alternative to traditional restorative dental material.
    Device Description
    SprintRay Digital Temp is a photo-polymer methacrylate resin material used in conjunction with a 3D printer and a scanned 3D image in a dental office to build dental prosthetics by 3D printing layer of the composite material. SprintRay Digital Temp resin is offered in various shades such as Bleach, A1, A2 and B1. Digital Temp is an alternative to traditional dental prosthesis material that is intended exclusively for professional dental work. SprintRay Digital Temp resin is intended exclusively for professional dental work. Fabrication of dental prosthetics with SprintRay Digital Temp resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: Digital Temp file created in an optical impression system, 3D printer, and curing light equipment. Digital Temp resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered nonsterile, and instructions on curing, and cleaning the final device prior to providing it to a patient are provided in the device indication for use document.
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    K Number
    K240538
    Device Name
    Premium Teeth Resin
    Manufacturer
    Formlabs Ohio, Inc.
    Date Cleared
    2024-07-19

    (144 days)

    Product Code
    EBG, PZY
    Regulation Number
    872.3770
    Why did this record match?
    Product Code :

    EBG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Premium Teeth Resin, when utilized to print 3D printed dental appliances such as denture teeth for complete and partial removable dentures, try-in dentures, provisional full arch implant-supported restoration and provisional restorations such as temporary crowns and bridges, inlays, onlays and veneers, is indicated to replace or restore missing tooth structures or missing teeth.
    Device Description
    Formlabs Premium Teeth Resin is a light-curable polymer-based resin of 3D printed dental appliances, such as denture teeth for complete and partial res, try-in dentures, provisional full arch implant-supported restoration, and provisional restorations including temporary crowns and bridges, inlays, onlays and veneers. Formlabs Premium Teeth Resin is used to fabricate patient-specific dental appliances in a stereolithographic (SLA) 3D printer using layer additive manufacturing.
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    K Number
    K241226
    Device Name
    Fixtemp® C&B 4:1
    Manufacturer
    Dreve Denatmid GmbH
    Date Cleared
    2024-05-31

    (29 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Product Code :

    EBG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fixtemp® C&B 4:1 is a resin-based material used to fabricate temporary crowns and bridges.
    Device Description
    Fixtemp® C&B 4:1 is an automatically mixable self-curing composite, used for the direct and indirect fabrication of temporary crowns and bridges. Fixtemp C&B 4:1 is a Type 1 – polymer-based material, per ISO 10477:2020. It is available in the tooth colors A1, A2, A3, A3.5, B1 and Bleach X.
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    K Number
    K233868
    Device Name
    dima Print Teeth & Temp
    Manufacturer
    Kulzer, LLC
    Date Cleared
    2024-05-23

    (169 days)

    Product Code
    EBG, POW, PZY
    Regulation Number
    872.3770
    Why did this record match?
    Product Code :

    EBG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Photopolymer for 3D printing of individualized, provisional and permanent prosthetic works. Indications - Long-term temporary restorations (up to 6 months), - Teeth for removable dentures
    Device Description
    dima Print Teeth & Temp is a photopolymer liquid for 3D printing of dental appliances. Its processing by dental healthcare professionals includes 3D printing, cleaning and curing. The final product produced by dental healthcare professionals will be an individual medical device for a special patient, inserted into the oral cavity, adapted and connected to the remaining residual teeth or functionally adapted to a given denture. Dima Print Teeth & Temp is offered in a range of colors.
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    K Number
    K223706
    Device Name
    PMMA BLOCK
    Manufacturer
    Huliang(shanghai) Bio-Tech Co., Ltd.
    Date Cleared
    2023-05-12

    (151 days)

    Product Code
    EBG, EBI, MQC
    Regulation Number
    872.3770
    Why did this record match?
    Product Code :

    EBG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PMMA BLOCK is used for the fabrication removable or temporary dental structures, such as crowns and bridges using milling technology using CAD/CAM. Indications for Use: - Temporary anterior and posterior crowns; - Temporary anterior and posterior bridges; - Removable structures for dentures; - Removable structures for therapeutic restorations (night guards, bite splints or occlusal splints).
    Device Description
    PMMA BLOCK is a circular solid (disc) or rectangular solid (block) of PMMA with or without post attachment for use in a CAD/CAM milling machine for production of provisional restorative prostheses such as dental crowns and bridges and removable dental structures. These blocks are available in a variety of shapes for different milling systems and are also available in variety of dental shades.
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