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510(k) Data Aggregation

    K Number
    K250489
    Device Name
    FP3D
    Manufacturer
    Keystone Industries
    Date Cleared
    2025-05-20

    (90 days)

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

    Keystone Industries

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FP3D is a dual cure resin indicated for the 3D printed fabrication of flexible partial dentures in dental laboratories.
    Device Description
    The FP3D is designed for additive manufacturing on Carbon 3D printers (wavelength = 385 nm). FP3D is intended to be used within a computer-aided design and manufacturing (CAD/CAM) digital dentistry system that includes a 3D scanner, design software, 3D printer, post-cure unit (wavelength = 385-405 nm), and post-cure oven for the fabrication of flexible partial dentures for partially edentulous patients.
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    K Number
    K241089
    Device Name
    KeyPrint KeyDenture Base
    Manufacturer
    Keystone Industries
    Date Cleared
    2024-10-24

    (188 days)

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

    Keystone Industries

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KeyPrint KeyDenture Base is a photopolymer resin indicated for the 3D fabrication of denture bases, including full and partial removable dentures, in dental laboratories. Fabrication requires a computer-aided design and manufacturing (CAD/CAM) system and 3D printer.
    Device Description
    KeyPrint KeyDenture Base is designed for additive manufacturing in vat polymerization 3D printers utilizing wavelengths between 385nm-405nm. KeyDenture Base is indicated for the fabrication of oral denture appliances for fully and partially edentulous patients. KeyDenture Base is intended to be used within a computer-aided and manufacturing (CAD/CAM) digital dentistry system that includes a 3D scanner, design software, 3D printer, and post-cure unit. For any components that are used in conjunction with the KeyDenture Base resin, the user should review all applicable product labeling including Instructions for Use, user manuals, and other associated labeling. Strict adherence to all labeling is critical in assuring a safe and effective printed appliance.
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    K Number
    K203000
    Device Name
    KeyPrint KeySplint Hard
    Manufacturer
    Mycone Dental Supply Co. Inc. (DBA Keystone Industries)
    Date Cleared
    2021-04-09

    (190 days)

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

    (DBA Keystone Industries)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KeyPrint® KeySplint Hard™ device is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners and retainers.
    Device Description
    KeyPrint® KeySplint Hard™ material is a UV-curable methacrylate-based resin, intended to be used by trained dental professionals for the 3D printing of various biocompatible dental devices such as mouthguards, splints, repositioners, and retainers. The printing of these devices is carried out using DLP printers utilizing pre-specified wavelengths. Each material is indicated for the fabrication of orthodontic and other dental appliances. Each material is recommended for the construction of specific Class I and II dental devices and appliances. In most cases, the devices are 3D printed to create custom devices or appliances.
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    K Number
    K183598
    Device Name
    KeyPrint KeySplint Soft
    Manufacturer
    Keystone Industries
    Date Cleared
    2019-11-15

    (324 days)

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

    Keystone Industries

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KeyPrint® KeySplint Soft™ device is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners.
    Device Description
    Not Found
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    K Number
    K172764
    Device Name
    Keymill
    Manufacturer
    Mycone Dental Supply Company, Inc. (aka Keystone Industries)
    Date Cleared
    2018-04-27

    (226 days)

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

    (aka Keystone Industries)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mycone Dental's High-Impact Denture Acrylic CAD/CAM Milling Disc material, known as Keymill, is intended to be used to form new dentures. It is intended to be used only by professional dental practitioners who make dentures for patients.
    Device Description
    Keymill High-Impact Denture Acrylic CAD/CAM Milling Disc
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    K Number
    K152051
    Device Name
    ClearMet
    Manufacturer
    Mycone Dental Supply Co., t/a Keystone Industries
    Date Cleared
    2016-03-22

    (243 days)

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

    , t/a Keystone Industries

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fabrication of removable dental prosthetic devices, such as full and partial dentures, occlusal splints and night guards.
    Device Description
    Not Found
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