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510(k) Data Aggregation

    K Number
    K220042
    Device Name
    Dentca Base Premium, Dentca Base Hi-Impact
    Manufacturer
    Dentca, Inc.
    Date Cleared
    2022-11-17

    (316 days)

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

    Dentca, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DENTCA Base Resin is a light-curable resin indicated for the fabrication and repair of removable denture bases in dental laboratories, including full and partial dentures as well as immediate dentures, and baseplates. DENTCA Base Resin can also be used for the fabrication of try-in dentures for the evaluation before fabricating the final dentures. Fabrication of these prostheses with DENTCA Base Resin requires a digital denture file, additive printer, and curing light equipment. DENTCA Base Resin can be utilized as an aid in bonding the denture teeth onto denture base.
    Device Description
    DENTCA Base Resin is a light-curable resin intended to fabricate removable dentures in a CAD/CAM system using an additive printing process. This material is used as an alternative to traditional heat cured and auto polymerizing denture base resins and is available in multiple shades. DENTCA Base Resin can also be utilized to repair the printed denture and to bond printed teeth onto denture base.
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    K Number
    K192806
    Device Name
    DENTCA Crown and Bridge
    Manufacturer
    Dentca, Inc.
    Date Cleared
    2020-02-05

    (127 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dentca, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DENTCA Crown and Bridge is a light-curable resin to fabricate, by additive manufacturing, temporary crowns or bridges. The fabricated temporary crowns or bridges are an alternative to preformed temporary crowns or bridges. The fabrication of temporary crowns or bridges with DENTCA Crown and Bridge requires digital models of crowns or bridges, a stereolithographic additive printer, and curing light equipment.
    Device Description
    DENTCA Crown and Bridge is a light-curable resin to fabricate, by additive manufacturing, temporary crowns or bridges.
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    K Number
    K172398
    Device Name
    DENTCA DENTURE Teeth
    Manufacturer
    DENTCA, INC.
    Date Cleared
    2017-11-22

    (106 days)

    Product Code
    PZY
    Regulation Number
    872.3590
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTCA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DENTCA Denture Teeth is a light-curable polymerizable resin to fabricate, by additive manufacturing, preformed denture teeth to be used in a denture.
    Device Description
    Not Found
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    K Number
    K162044
    Device Name
    Dentca Denture Base II
    Manufacturer
    DENTCA, Inc.
    Date Cleared
    2017-03-03

    (221 days)

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

    DENTCA, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DENTCA Denture Base II is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with Dentca Denture a computer-aided design and manufacturing (CAD/ CAM) system that includes the following components: digital denture base files based on a digital impression, stereolithographic additive printer, and curing light equipment.
    Device Description
    Not Found
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    K Number
    K143033
    Device Name
    DENTCA DENTURE BASE
    Manufacturer
    DENTCA, INC.
    Date Cleared
    2015-07-21

    (272 days)

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

    DENTCA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dentca Denture Base is a light-cured resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-cured and auto polymerizing resins. Fabrication of dental prosthetics with Dentca Denture Base requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, stereolithographic additive printer, and curing light equipment.
    Device Description
    Dentca Denture Base is a photosensitive resin intended to fabricate removable dentures in a CAD/CAM additive printing process. The Dentca polymer is a viscous solution of the following compounds: methacrylate-based resins, a photoinitiator that activates at 405 nm visible (blue) light, an inhibitor, and pigments. It comes in two sizes, large and small bottles (see photo at right). It is a Type 4 (lightactivated) acrylic resin as classified by ANSI/ADA Specification No. 12. The denture fabrication process begins with a traditional casting impression of the oral region in the dentist office. This impression is sent to a dental lab for conversion to digital image in an optical impression system. The denture base is then made layer-by-layer in a stereolithographic laser printer. After attachment of preformed plastic teeth, the denture is cured in a light chamber, and, lastly, sent back to the dentist for try-in and final adjustment.
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