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510(k) Data Aggregation

    K Number
    K231389
    Device Name
    Harvest Dental HD Gum Strip
    Manufacturer
    Harvest Dental Products, LLC
    Date Cleared
    2023-08-16

    (96 days)

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

    Harvest Dental Products, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Harvest Dental HD Gum Strip is indicated for adding texture, form and color to the gingival area of a dental prosthesis which includes crowns, bridges and full and partial prostheses. This composite strip is bondable to polymethylmethacrylate (PMMA), metals and ceramics (zirconia).
    Device Description
    Harvest Dental HD Gum Strip is a bondable, light-cured composite for adding texture and color to the gingival area of a dental prosthesis which includes crowns, bridges and full and partial prostheses. This composite strip is bondable to polymethylmethacrylate (PMMA), metals and ceramics (zirconia). It is provided in a textured, malleable strip meant to be applied to a dentine/bone-like substructure. The strip is an alternative to the method of using a shaded composite paste to manually build-up and model visible gingival surfaces to look similar to natural gingival tissues. The Harvest Dental HD Gum Strip includes features such as gingival veins formed into its surface as well as being available in various shades of coloration. The strip can be easily cut, applied to the gingival surface of the restoration, then trimmed and finished with appropriate features such as gingival line and interdental papilla. Gum Strip Modifiers (paste versions of the same composite) are available in various shades and used for additional surface features and gingival repairs, and Liquid Modifiers (stains, which are a low-viscosity color-concentrated form of the same composite) are available in several shades and used for enhanced coloration resembling the natural gingiva. The Harvest Dental HD Gum Strip is bonded to the dental prosthesis utilizing a bonding adhesive provided with the strip and modifiers and, after any final detailing and coloring, is to be cured utilizing a typical light-curing device.
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    K Number
    K222961
    Device Name
    Harvest Conceal ZR Block Out
    Manufacturer
    Harvest Dental Products, LLC
    Date Cleared
    2023-06-02

    (248 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Harvest Dental Products, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Harvest Conceal ZR Block Out is indicated for burn-in zirconia shading. The applied liquid is sintered with the zirconia to adjust the restoration to match the natural color of the patient's teeth. The material is intended for professional dental work only.
    Device Description
    Harvest Conceal ZR Block Out is a water-based opacifying solution available in 5 shades. white, A1, B1, C1 and D2, for use with a translucent zirconia core. It is indicated for burn-in zirconia shading. The applied liquid is sintered with the zirconia to adjust the restoration to match the natural color of the patient's teeth. Fabrication using the Harvest Conceal ZR Block Out requires an appropriate drying oven and sintering furnace.
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    K Number
    K222489
    Device Name
    Harvest Printable Resin
    Manufacturer
    Harvest Dental Products, LLC
    Date Cleared
    2023-05-12

    (268 days)

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

    Harvest Dental Products, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Harvest Printable Resin is indicated for the fabrication of dental bases for full removable dentures, artificial teeth, dental bite splints and guards and try-in devices, i.e., denture base and teeth. The material is an alternative to traditional heat-curable and auto-polymerizing resins and is intended for professional dental work only. This material is intended to be used by dental lab technicians and approved by licensed practitioners before being provided to the patient.
    Device Description
    Harvest Printable Resin is a light-cured resin developed for additive manufacturing (3D printing) of individual full denture bases, artificial teeth, bite splints and guards and try-in devices, i.e., denture base and teeth. After being utilized in a 3D stereolithographic printer to generate a dental device based on a solid model, the device is placed in a UV light curing unit for final polymerization. Fabrication using Harvest Printable Resin requires an appropriate computer-aided Design and Manufacturing (CAD/CAM) system, a digital light processing (DLP) printer, and post-processing light curing equipment. It has been optimized for use with Asiga (Max UV, Pro 4K65 and Pro 4K80) and Sprintray (Pro95 S and Pro55 S) printers and, therefore, may only be used in conjunction with these printers and their associated software systems. It is also only to be used in conjunction with Asiga (Max UV, Pro 4K65 and Pro 4K80) and Sprintray (Procure and Procure 2) curing units for post-processing. The 3D printer is not included with the device.
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    K Number
    K180578
    Device Name
    Harvest Dental Polymer Blocks
    Manufacturer
    Harvest Dental Products, LLC
    Date Cleared
    2018-12-12

    (282 days)

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

    Harvest Dental Products, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the fabrication of crowns, bridges and structures for implant supported provisional removable denture and appliance prosthetics. -Provisional anterior and posterior crowns & bridges - Implant and abutment supported prosthetics. - Partial, complete and hybrid denture prosthetics (base and teeth) - Removable appliances (splint)
    Device Description
    Harvest Dental Polymer Blocks are industrially polymerized, pre-colored or clear dental milling discs and blocks designed for milled fabrication of temporary anterior and posterior crowns and bridges (tooth-colored variants) or bite splints and dental CAD/CAM systems.
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    K Number
    K132937
    Device Name
    HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA)
    Manufacturer
    HARVEST DENTAL PRODUCTS, LLC
    Date Cleared
    2014-05-21

    (245 days)

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

    HARVEST DENTAL PRODUCTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Harvest Dental Polymer Blocks (ZCAD) are PMMA blanks for manufacturing temporary crowns and bridges by a CAD/CAM system.
    Device Description
    Harvest Dental Polymer Blocks (ZCAD) are PMMA blanks.
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