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510(k) Data Aggregation

    K Number
    K150295
    Device Name
    LOCATOR RTx
    Manufacturer
    ZEST ANCHORS, INC.
    Date Cleared
    2015-07-24

    (168 days)

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

    ZEST ANCHORS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LOCATOR® RTx Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. LOCATOR® RTx Attachment System is compatible with the following implant systems. | Implant Manufacturer: | System: | |-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | BioHorizons | Internal Hex (3.0, 3.5, 4.5, 5.7 mm)<br>External Hex (3.5, 4.0, 5.0 mm) | | Biomet 3i | Certain Internal (3.4, 4.1, 5.0, 6.0 mm)<br>External Hex (3.4, 4.1, 5.0, 6.0 mm) | | Camlog | Camlog and Conelog; (3.3, 3.8, 4.3, 5.0 mm)<br>iSy (3.8, 4.4, 5.0 mm) | | Dentsply | Ankylos (3.5, 4.5, 5.5, 7.0 mm)<br>XiVE/FRIALIT-2 (3.4, 3.8, 4.5, 5.5 mm)<br>Astra Tech OsseoSpeed EV (3.6, 4.2, 4.8 mm) | | MIS Implants | Internal Hex (3.75, 4.5 mm) | | Nobel Biocare | Replace: Internal (3.5, 4.3, 5.0, 6.0 mm),<br>NobelActive: Internal Conical (3.0, 3.5, 4.3, 5.0 mm),<br>Brånemark: External Hex (3.3, 3.75, 4.0, 5.0 mm) | | Straumann | Tissue Level (3.5, 4.8, 6.5 mm)<br>Bone Level (3.3, 4.1, 4.8 mm) | | Zimmer | Tapered Screw Vent: Internal Hex (3.5, 4.5, 5.7 mm)<br>Spline (3.25, 4.0, 5.0 mm)<br>Swiss Plus: Internal Octagon (3.8, 4.8 mm) |
    Device Description
    LOCATOR® RTx implant attachment system, consists of abutments, nylon or PEEK liners and denture caps to serve in a similar function to LOCATOR® as a resilient attachment for endosseous implants. All LOCATOR RTx abutments are made of titanium alloy and have the same coronal double ridge retention design that attaches to the overdenture component. The threaded apical end of the abutment connects to the implant and is specific to each compatible implant system and diameter. LOCATOR RTx is designed to accommodate a path of insertion on implants that are divergent up to 30° unless prohibited by the implant manufacturer. LOCATOR RTx abutments are provided with either TiCN or TiN coating and are available in six cuff heights (1, 2, 3, 4, 5, and 6 mm). They are provided in diameters 3.0 - 7.0 mm as shown in the compatibility table above.
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    K Number
    K083324
    Device Name
    LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM
    Manufacturer
    ZEST ANCHORS, INC.
    Date Cleared
    2009-02-25

    (105 days)

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

    ZEST ANCHORS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Locator Implant Anchor Abutment for Endosseous Dental Implants is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla. The Locator Implant Bar Attachment System for Endosseous Dental Implants is appropriate for use with overdentures or partial dentures retained in whole or in part by bar splinted endosseous implants in the mandible or maxilla.
    Device Description
    Not Found
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    K Number
    K072878
    Device Name
    MODIFICATION TO: LOCATOR IMPLANT ANCHOR
    Manufacturer
    ZEST ANCHORS, INC.
    Date Cleared
    2007-12-03

    (55 days)

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

    ZEST ANCHORS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K042466
    Device Name
    X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE
    Manufacturer
    ZEST ANCHORS, INC.
    Date Cleared
    2004-11-24

    (72 days)

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

    ZEST ANCHORS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The X-2 Implant Attachment is designed for use with overdentures or partial dentures, retained in whole or in part by endosseous implants in the mandible or maxilla. The X-2 Bar Attachment System is designed for use with overdentures or partial dentures retained in whole or in part by bar splinted endosseous implants in the mandible or maxilla. The X-2 Distal Extension Attachment System is designed for use with partial dentures retained in whole or in part by bar splinted endosseous implants and crowned roots with a distal extension in the mandible or maxilla.
    Device Description
    Not Found
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    K Number
    K033699
    Device Name
    LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586
    Manufacturer
    ZEST ANCHORS, INC.
    Date Cleared
    2004-04-22

    (149 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZEST ANCHORS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Locator Bar Attachment System is designed for use with overdentures or partial dentures retained in whole or in part by bar splinted endosseous implants in the mandible or maxilla.
    Device Description
    Not Found
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    K Number
    K994257
    Device Name
    LOCATOR IMPLANT ANCHOR
    Manufacturer
    ZEST ANCHORS, INC.
    Date Cleared
    2000-03-17

    (92 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZEST ANCHORS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Locator Implant Anchor abutment for endosseous dental implants is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.
    Device Description
    The Locator Implant Anchor is an abutment for endosseous implants.
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