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510(k) Data Aggregation

    K Number
    K170372
    Device Name
    SpiralTech Dental Implant System
    Manufacturer
    SpiralTech Superior Dental Implants, Inc.
    Date Cleared
    2017-06-30

    (143 days)

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

    SpiralTech Superior Dental Implants, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spiraltech Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients esthetics and chewing function. Spiraltech implants are intended for single or multiple unit restorations on splinted or non-splinted applications. The implants ESi Dynamic and Ultimate are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants [along with Premium and One Piece] can also be used for loading after a conventional healing period. Solo One Piece 3.0 and 3.3 implants, Ultimate (conical) 3.0 implants, and ESi (conical) 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.0 and/or 3.3 implants adjacent to one another.
    Device Description
    The SpiralTech implant system is a comprehensive product line that includes implants, corresponding abutments, and closure screws. SpiralTech dental implants are grade 5 titanium (Ti 6Al-4V ELI, conforms to ASTM F136) implants that come in 2 different surface treatments - SLA, and RBM. SpiralTech dental implants come in five product lines with four based on their thread designs. The ESi has sharp, square, and rounded threads. The Ultimate and Dynamic lines also have sharp threads with the Dynamic having a reverse buttress thread design. The Premium line features square and sharper threads in a more conventional design. The implants have diameters ranging from 3.0 mm, and the lengths from 8mm to 15 mm. ESi, Ultimate, and Dynamic are intended to be used for immediate loading. The fifth implant type is the One Piece which comes with an abutment which cannot be used with low mechanical stability cases. Abutments are available in various types including straight, shoulder, angulated, ball attachments, multiunit, temporary and healing. All abutments come in both hex and conical connections. Temporary abutments come in PEEK and zirconia. Healing abutments come in titanium alloy and zirconia. Abutments come in titanium alloy and as a titanium base with zirconia abutments and multi-units are titanium alloy. No SpiralTech abutments are intended to be modified.
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