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510(k) Data Aggregation

    K Number
    K020391
    Device Name
    STERN MICRO ERA ATTACHMENT SYSTEM
    Manufacturer
    STERNGOLD
    Date Cleared
    2002-03-08

    (30 days)

    Product Code
    DZE
    Regulation Number
    872.3640
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    Matched: '872.3165'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stern Micro ERA System is a resilient retention device for dental prosthesis, designed to be used in restoration of removable dentures.
    Device Description
    Device consists of a series of nylon male attachments in six variable sizes to provide six levels of retention. The six levels of retention are color coded - white, orange, blue, gray, yellow, and red (in order of increasing degrees of retention). Variations in the degree of retention are incorporated to facilitate requirements of individual patients. It also includes a black processing (also referred to as fabricating) male that is not used in the mouth for retention of the finished denture, but only used as a tool to incorporate the final snap-in male into the finished dental appliance. A resin female is also incorporated in this system, along with stainless steel and titanium alloy instruments.
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    K Number
    K993894
    Device Name
    LIFECORE SINGLE TOOTH ABUTMENT SYSTEM
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Date Cleared
    2000-03-08

    (113 days)

    Product Code
    DZE
    Regulation Number
    872.3640
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    Matched: '872.3165'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lifecore Single Tooth Abutment is intended to attach to an endosseous implant and provide support and retention for a single-tooth restoration in the mandible or maxilla.
    Device Description
    The Lifecore Single Tooth Abutment System is designed for use with an endosseous dental implant and provides support and retention for cement-retained, single tooth restorations in the mandible or maxilla. The system consists of the single tooth abutments, abutment screws, healing caps, impression posts, and associated laboratory components. Most components are packaged separately to allow the clinician to choose only those components required for each clinical situation. The Lifecore Single Tooth Abutment System has been designed to be dimensionally compatible with the Nobel Biocare CeraOne® Abutment System gold and ceramic sleeves. The single tooth abutments and healing caps are manufactured from titanium allov (Ti 6Al-4V E.L.I.).
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    K Number
    K970776
    Device Name
    LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENT
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Date Cleared
    1997-05-27

    (84 days)

    Product Code
    DZE
    Regulation Number
    872.3640
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lifecore Sustain and Restore Dental Implant Systems are intended for use in either partially or fully edentulous mandibles or maxillae in the following areas: - Support of fixed (cemented) restorations utilizing multiple abutments; . - Support of fixed detachable (screw retained) prosthetics utilizing multiple abutments; ● - Overdenture retention by means of a ball overdenture attachment, o-ring attachment, dalla bona or hader bar; - Terminal or interniedlate abutment support for fixed bridgework; . - Free standing restorations without involvement of adjacent dentition.
    Device Description
    The abutment is designed for use with an endosseous implant which is implanted in the lower or upper jaw. The abutment is used as an attachment solution to overdentures.
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    K Number
    K965135
    Device Name
    LIFECORE CONICAL ABUTMENT
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Date Cleared
    1997-02-25

    (64 days)

    Product Code
    DZE
    Regulation Number
    872.3640
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    Matched: '872.3165'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Implant systems are for use in single tooth, partially edentulous, completely edentulous, mandibles and maxillae as a support or attachment for prosthetic restoration. The restoration can be detachable (screw relained) prosthetics in multiple, free standing or terminal restorations.
    Device Description
    The conical abutment is designed for use with an endosseous implant which is implanted in the lower or upper jaw. The conical abutment provides a base for the restorative crown or bridgework.
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