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510(k) Data Aggregation

    K Number
    K212676
    Device Name
    Osteon Precision Milled Suprastructure
    Manufacturer
    Implant Solutions PTY LTD (Osteon Medical)
    Date Cleared
    2022-03-03

    (191 days)

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

    Implant Solutions PTY LTD (Osteon Medical)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Osteon Precision Milled Suprastructure is indicated for attachments in the treatment of partially orfully edentulous for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments. The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems: - · Nobel Biocare Multi Unit Abutment Plus, 4.8mm, max 30° - · Nobel Biocare Xeal Abutments, 4.8mm, max 30° - · Nobel Biocare Multi Unit Abutment, 4.8mm, max 30° - MIS Multi-unit Abutments, 4.8mm - · C1 Conical Connection Implant System, max 30° - · V3 Conical Connection Implant System, max 30° - · Internal Hex Implant System, max 30° - · Conical Connection, max 30° - Southern Compact Conical Abutments, 4.8mm - · MAX Implant System, 0° - · Provata Implant System, max 30° - · Deep Conical (DC) Implants, 0° - · Piccolo Implants, 0° - · External Hex Implants, max 30° - · Astra Tech Implant System® Multi Base Abutment EV, 4.8mm, max 30° - Keystone Multi Unit Abutment, 4.8mm, 0° - · Neodent GM Mini Conical Abutment, 4.8mm, max 30° - · Implant Direct GPS® Angled Abutment, 5.0mm, max 30° - · Dentium SuperLine® Abutments, 4.5-5.5mm, max 30° - · Zimmer Angled Tapered Abutments, 4.5mm, max 30° - · Paltop Multi Unit Abutment, 5.0mm, max 17°
    Device Description
    The Osteon Precision Milled Suprastructures (also referred as superstructures) are metallic dental restorative device that is intended for attaching by screw retention to dental abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring their chewing function. These suprastructures attach to previously-cleared original equipment manufacturers (OEM) dental abutments using the (OEM) prosthetic screws. The abutmentborne subject devices are indicated for placement only on OEM implant/abutment constructs placed according to the labeling of the previously-cleared systems, and not to exceed the maximum angulation allowed for each OEM implant/abutment construct as identified in the Indications for Use Statement of the subject system. The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's impression. The suprastructure is manufactured in biocompatible Titanium alloy with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical, within our premises. Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence categorized as type A and type B.
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