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510(k) Data Aggregation

    K Number
    K250279
    Device Name
    RC-SwiftPrep
    Manufacturer
    Belport Company, Inc., Gingi-Pak
    Date Cleared
    2025-07-02

    (152 days)

    Product Code
    KJJ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Belport Company, Inc., Gingi-Pak

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250222
    Device Name
    SDF Pro
    Manufacturer
    Belport Company, Inc., Gingi-Pak
    Date Cleared
    2025-05-07

    (100 days)

    Product Code
    PHR
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    Belport Company, Inc., Gingi-Pak

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SDF Pro is intended to be used by dental professionals to treat tooth hypersensitivity. For use in adults over the age of 21.
    Device Description
    Not Found
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    K Number
    K240688
    Device Name
    RODIN Titan 3D Resin
    Manufacturer
    Belport Company, Inc., Gingi-Pak
    Date Cleared
    2024-06-20

    (99 days)

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

    Belport Company, Inc., Gingi-Pak

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rodin Titan 3D Resin is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supported denture prosthetics, monolithic full and partial removable denture teeth to be used in a denture. It is indicated as a permanent restorative for both anterior restorations, including occlusal surfaces. It is used for fabricating permanent restorations such as inlays, veneers and full crown restorations.
    Device Description
    RODIN Titan 3D Resin consists of a curable dental acrylate resin that is manufactured in a dental office based on a 3D scanned image of a patient's teeth. The acrylate resin material is designed to be used in conjunction with a scanned 3D image, and 3D printer assembly, to locally manufacture out a dental appliance based on the clinician's judgment of patient need. Fabrication of dental prosthetics with RODIN Titan 3D Resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: oral casting impression, digital denture file created in an optical impression system, 3D printer, and curing light equipment. The material is an alternative to traditional dental prostheses material Rodin Titan 3D Resin is intended exclusively for professional dental work. RODIN Titan 3D Resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.
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    K Number
    K231060
    Device Name
    ProMin Dental Desensitizing Gel
    Manufacturer
    Belport Company, Inc., Gingi-Pak
    Date Cleared
    2024-06-13

    (427 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    Belport Company, Inc., Gingi-Pak

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K231793
    Device Name
    RODIN 3D Resin SPLINT, Hard/Flex
    Manufacturer
    Belport Company, Inc., Gingi-Pak
    Date Cleared
    2024-03-26

    (280 days)

    Product Code
    MQC, KMY
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Belport Company, Inc., Gingi-Pak

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RODIN Splint is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, splints and repositioners.
    Device Description
    Not Found
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    K Number
    K223365
    Device Name
    RODIN Palette Naturalizing Kit
    Manufacturer
    Belport Company, Inc., Gingi-Pak
    Date Cleared
    2023-03-27

    (144 days)

    Product Code
    EBD
    Regulation Number
    872.3310
    Why did this record match?
    Applicant Name (Manufacturer) :

    Belport Company, Inc., Gingi-Pak

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Characterization of provisionals. Characterization of direct & indirect composite restorations, acrylic denture base and artificial acrylic teeth. Characterization of C&B composite resin restorations or acrylic resin.
    Device Description
    Not Found
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    K Number
    K211420
    Device Name
    Stasis Gel
    Manufacturer
    Belport Company, Inc., Gingi-Pak
    Date Cleared
    2022-03-14

    (311 days)

    Product Code
    MVL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Belport Company, Inc., Gingi-Pak

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    STASIS Gel is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. STASIS Gel facilitates the insertion of the cord into the sulcus.
    Device Description
    Stasis Gel is a 15.5% Ferric Sulfate in a water-based, viscous gel that facilitates sulcus retraction. When applied to the sulcus, the product provides physical displacement of the gingival tissue from the tooth, which in turn, provides a physical barrier to prevent gingival bleeding and oozing from following procedures. Stasis Gel is supplied in a 30 ml or 1.2 ml plastic syringe. The 30 ml syringe is used for bulk storage and 1.2 ml plastic syringe is used for delivery the gel to the sulcus.
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    K Number
    K211419
    Device Name
    Gingi-Aid Gel
    Manufacturer
    Belport Company, Inc., Gingi-Pak
    Date Cleared
    2022-01-10

    (248 days)

    Product Code
    MVL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Belport Company, Inc., Gingi-Pak

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GINGI-AID Gel is intended for gingival retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry when used with gingival retraction cords. The gel facilitates the insertion of the cord into the sulcus.
    Device Description
    Gingi-Aid Gel is a 25% Aluminum Chloride in a water-based, viscous gel that facilitates gingival retraction. When applied to the sulcus, the product provides physical displacement of the gingival tissue from the tooth, which in turn, provides a physical barrier to prevent gingival bleeding and oozing from following procedures. Gingi-Aid Gel is supplied in a 30 ml or 1.2 ml plastic syringe. The 30 ml syringe is used for bulk storage and 1.2 ml plastic syringe is used for delivery the gel to the sulcus.
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    K Number
    K200462
    Device Name
    EtchPro Etching Gel
    Manufacturer
    Belport Company, Inc., Gingi-Pak
    Date Cleared
    2020-09-02

    (190 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Belport Company, Inc., Gingi-Pak

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EtchPro® Etching Gel is intended to be used by dental professionals to etch the dentin and enamel before tooth restoration treatments.
    Device Description
    EtchPro® Etching Gel is a 38% phosphoric acid etching gel in a soft gel form that is used by dental professionals for etching dentin and enamel before tooth restoration.
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