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510(k) Data Aggregation

    K Number
    K241616
    Device Name
    ALLONUS Tech Prosthetics
    Date Cleared
    2024-12-17

    (195 days)

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

    ALLONUS Tech Co., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ALLONUS Tech Prosthetic is intended for use with dental implants as a support for single or multiple-unit prosthetic restorations in the maxilla or mandible of partially or fully edentulous patient. It is including; cemented retained, screw-retained, or overdenture restorations. It is compatible with the following systems: - · Astra OsseoSpeed EV(K130999) 3.0 - · Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm - Tapered Internal Implants (K071638) (K143022) 3.4. 3.8. 4.6. 5.8 mm - · BioHorizons Laser-Lok Implant System (K093321) 3.0 mm - · Conelog Screw-Line (K113779) 3.3, 3.8, 4.3, 5.0 mm - Osstem TSIII SA (K121995) 3.5 (3.7) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1), 6.0 (6.0), 7.0 (6.8) mm (Mini. Regular) - · Megagen AnyRidge Internal Implant System (K140091) 4.0, 4.4, 4.9, 5.4 (3.1) - · Neodent Implant System GM Helix (K163194, K180536) 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0) - · Nobel Active 3.0 (K102436) 3.0 - · Nobel Active Internal Connection Implant (K071370) NP RP - · Nobelactive Wide Platform (Wp) (K133731) WP - Straumann BLX Implant (K173961, K181703, K191256) 3.5, 3.75, 4.5, 5.5, 6.5 (RB, WB) - · Straumann 02.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890) 2.9 (SC) - · Straumann® Bone Level Tapered Implants (K140878) 3.3, 4.1, 4.8 (NC, RC) - · Zimmer 3.1mmD Dental Implant System (K142082) 3.1 (2.9) - (Ti-base only) Screw Vent® and Tapered Screw Vent® (K013227) 3.7(3.5), 4.7(4.5), 6.0(5.7) All digitally designed abutments and/or coping for use with the abutments are intended to be sent to a ALLONUS Tech-validated milling center for manufacture.
    Device Description
    ALLONUS Tech Prosthetic is made of titanium alloy (Ti-6AI-4V ELI, ASTM F136) intended for use as an aid in prosthetic restoration. It consists of Pre-Milled Blank abutment, Ti-Base Abutment, and Multi-unit Abutment and Components (Multi-unit Healing Cap, Multi-unit Temporary cylinder, Multi-unit Ti-cylinder). Pre-Milled Blank has a pre-manufactured implant interface connection interface with a customizable cylindrical area-by CAD/CAM- above the implant-abutment interface. Ti Base consists of a two-piece abutment, where the titanium base is a pre-manufactured component of the abutment that will be used to support a CAD/CAM-designed zirconia superstructure (the second part of the two-piece abutment) that composes the final abutment. Multi-unit Abutment which are placed into the dental implant to provide support for the prosthetic restoration. The abutments are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Multi-unit Abutment includes abutments and components (Multi-unit Healing Cap, Multi-unit Temporary cylinder, Multi-unit Ti-cylinder). Multi-unit Abutment - are provided in various gingival cuff height ranging from 1 to 6 mm. All digitally designed abutments and/or coping for use with the abutments are intended to be sent to a ALLONUS Tech-validated milling center for manufacture.
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