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510(k) Data Aggregation

    K Number
    K251205

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-11-21

    (217 days)

    Product Code
    Regulation Number
    872.3630
    Panel
    Dental
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Atlantis Abutment & Atlantis Abutment Milling
    The Atlantis Abutment and Atlantis Abutment Milling are intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant.

    Atlantis Crown Abutment
    The Atlantis Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The Atlantis Abutment screw is intended to secure the Atlantis Crown Abutment to the endosseous implant.

    Atlantis Conus Abutment
    The Atlantis Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is an attachment-retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant.

    Atlantis Healing Abutment
    The Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The Atlantis Abutment screw is intended to secure the Atlantis Healing Abutment to the endosseous implant.

    Implant Manufacturer: Institut Straumann
    Implant System: Straumann BLX
    Implant Diameter (in mm): 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5
    Abutment Platform Diameter (in mm): 2.69

    Implant System: Neodent GM
    Implant Diameter (in mm): 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0
    Abutment Platform Diameter (in mm): 3.0

    Device Description

    The Atlantis® Abutments in Titanium are patient-specific dental abutments that are intended for attachment to dental implants in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The design of the Atlantis® Abutments in Titanium is derived from patient dental models and is completed by Dentsply Sirona using computer-assisted design (CAD) technology according to the clinician's prescription. The final CAD design of the Atlantis® Abutment in Titanium is fabricated using computer-assisted manufacturing (CAM) to produce a customized, patient-specific device. Design and fabrication of the Atlantis® Abutment in Titanium is completed in internal Dentsply Sirona manufacturing facilities.

    Alternatively, the CAD design, according to the clinician's prescription, can be performed by a laboratory or clinician in an FDA cleared abutment design software (3Shape Abutment Designer Software, K151455) within the design envelope of the Atlantis® Abutments which is codified in the validated and locked design library of the cleared software. Fabrication of the Atlantis® Abutment is then completed in internal Dentsply Sirona manufacturing facilities.

    The Atlantis® Abutment in Titanium serves as a connection of the prosthetic construction and the endosseous implant. The lower part of the abutment is designed to fit with the specific implant geometry it is compatible, and the upper part design is according to the patient's specific anatomy. The Atlantis® Abutment, including the Conus and Healing abutments further described below, are available in Titanium or Gold-shaded (titanium nitride layer applied using PVD (Physical Vapor Deposition)) Titanium. The Crown Abutment which is another Atlantis® Abutment in Titanium, is only available in Titanium.

    The Atlantis® Abutment design envelope became the basis for the other more specific designs that make up the Atlantis® Abutments in Titanium. The Atlantis® Abutment is intended for use with an endosseous implant and for single tooth restoration.

    The Atlantis® Crown Abutment in Titanium is also a custom fabricated abutment using the same internal CAD/CAM technology. The Atlantis® Crown Abutment in Titanium incorporates a design that is a combination of an abutment and an anatomically accurate crown to constitute the final finished device. It functions as a substructure that also serves as the final abutment, in a partially or completely edentulous patient.

    The Atlantis® Conus Abutment supports a removable prosthesis (bridges and overdentures) which is retained by friction fit to the abutment. The abutment connects to the prosthesis via caps embedded in the prosthesis.

    The Atlantis® Healing Abutment is used with the compatible implants for temporary use during soft tissue healing after one-stage and two-stage surgeries. It is designed based on the planned final Atlantis® Abutment or Atlantis® Crown Abutment, using the same emergence profile as those abutments to achieve an aesthetic outcome during the soft tissue healing phase.

    The proposed Atlantis® Abutments in Titanium for Straumann BLX Implant are compatible with the Straumann BLX Implants. This implant system is available in diameters of 3.5, 3.75, 4.0, 4.5 5.0, 5.5 and 6.5 mm and in lengths of 8, 10, 12, 14, 16, and 18 mm all with identical mating geometry.

    The proposed Atlantis® Abutments in Titanium for Neodent GM Implant are compatible with the Neodent GM Implants. This implant system is available in diameters of 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, and 7.0 mm and in lengths of 7, 8, 9, 10, 11, 11.5, 13, 15, 16, 17 and 18 mm, all with identical mating geometry.

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