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510(k) Data Aggregation

    K Number
    K193425
    Device Name
    Pre-Milled Blank
    Manufacturer
    Arum Dentistry Co. Ltd
    Date Cleared
    2020-03-09

    (90 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Arum Dentistry Co. Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ARUM Dentistry's Pre-Milled Blank abutments are intended for attachment to dental implants in order to provide support for customized prosthetic restorations. Pre-Milled Blank abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. The customized Pre-Milled Blank abutment will be attached to a dental implant using the included ARUM Dentistry prosthetic screw. ARUM Dentistry's Pre-Milled Blanks are compatible with the implant systems listed in the Compatibility Table: | ARUM Pre-Milled Blank | | Implant Platform<br>compatibility | Restorative Platform<br>diameter [mm] | Implant Body<br>diameter [mm] | Abutment<br>Screw | |-----------------------|---------|-----------------------------------|---------------------------------------|-------------------------------|-------------------| | Ø10 mm | Ø14 mm | | | | | | CIHE037 | CIHE038 | NobelActive NP | 3.5 | 3.5 | CSTO001 | | CIHE039 | CIHE040 | NobelActive RP | 3.9 | 4.3/5.0 | CSTO002 | | CIHE135 | CIHE136 | NobelActive WP | 5.1 | 5.5 | CSTO002 | All digitally-designed Pre-Milled Blank abutments are intended to be sent to an ARUM Dentistry-validated milling center for manufacture.
    Device Description
    ARUM Dentistry Co., Ltd.'s Pre-Milled Blank abutments are a system of dental implant abutments which have an implant /abutment interface design compatible with the Reference device OEM Nobel Biocare NobelActive implant system. Each Subject device implant abutment has a pre-manufactured implant interface connection interface with a customizable cylindrical section above the implant/abutment interface. The compatible implant body diameters range from 3.5 to 5.5 mm, with restorative interface diameters ranging from 3.0 to 5.1 mm (NP, RP and WP diameters). The Subject device abutments and corresponding abutment screws are all pre-manufactured from Ti-6Al-4V ELI (Grade 23) titanium conforming to ASTM F136 and provided non-sterile to the user. The Subject device abutments are in two customizable-section diameters for each restorative interface. The cylindrical section of the Subject device abutments are intended to be customized by means of CAD/CAM technology to provide basis or support for single or multiple tooth prosthetic restorations. All digitally designed custom abutments from titanium blank abutments are to be sent to an ARUM Dentistry Co., Ltd.-validated milling center for manufacture.
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