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510(k) Data Aggregation

    K Number
    K252944
    Device Name
    LOCATOR® Angled Abutment
    Manufacturer
    Zest Anchors, LLC
    Date Cleared
    2025-10-15

    (30 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K151621,K240187,K192218,K250721
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K151621, K240187, K192218

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LOCATOR Angled Abutment is indicated for the attachment of full or partial, fixed and removable restorations retained by endosseous implants to restore masticatory function for the patient.

    Device Description

    The purpose of this submission is to expand the indications of the LOCATOR® Angled Abutment product line to include use with new dental implant systems. This was achieved through collaboration with the implant manufacturers BioHorizons and Implant Direct to prove compatibility of the design of the implant to abutment connection, and equivalence of design specification and performance characteristics.

    Previously, the LOCATOR Angled Abutment has been cleared by FDA in applications K233587, K243272, and K250721 for use with various dental implant systems by the manufacturers BioHorizons, Implant Direct, Implant Logistics, Neodent, Nobel Biocare, Straumann, and ZimVie (Zimmer). These LOCATOR Angled Abutments are also designed and cleared for use with removable LOCATOR® Attachment Systems (K072878) and LOCATOR FIXED® (K213391), intended for the attachment of full or partial, fixed and removable, restorations retained by endosseous implants in the mandible or maxilla. This 510(k) submission expands the indications of the LOCATOR Angled Abutment product line with new connections compatible with the following implant systems from BioHorizons (Camlog) and Implant Direct.

    • BioHorizons Tapered 3.0 (Internal Hex)
    • BioHorizons Tapered Pro Conical Narrow platform (CONELOG)
    • BioHorizons Tapered Pro Conical Regular platform (CONELOG)
    • BioHorizons Tapered Short Conical Regular platform (CONELOG)
    • Implant Direct Legacy 3, 3.0mmD

    Compatibility of the new LOCATOR Angled Abutments and screws with either the BioHorizons or Implant Direct implants has been demonstrated through documented collaboration with the OEM. This was achieved by utilizing the OEM's design specifications, which were shared with Zest to create a LOCATOR Angled Abutment and screw that is equivalent to the implant manufacturer's own abutment device in how it interfaces with their respective implant system(s). Additionally, the LOCATOR Angled Abutment parameters deemed critical to ISO 14801 fatigue testing are also equivalent to the manufacturer's cleared abutment specifications, and therefore do not create a new worst case construct or condition. An equivalent specification is deemed as being identical to or within the OEM's defined specification.

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