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510(k) Data Aggregation

    K Number
    K192839
    Device Name
    DSP Implant System
    Manufacturer
    D.S.P Industrial Eireli
    Date Cleared
    2021-02-11

    (504 days)

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

    D.S.P Industrial Eireli

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DSP Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
    Device Description
    DSP Implant System is composed of the External Hex (HE) implant line is composed of implants and related prosthetic components available in multiple designs. DSP implants are made of commercially pure titanium (ASTM F67). DSP prosthetic components are made of commercially pure titanium or cobalt-molybdenum alloy (ASTM F1537). DSP implant system screws (abutment and prosthetic screws) are made of titanium alloy (ASTM F136). The HE implant line is named after the External Hex implant-to-abutment interface. It is subdivided in External Hex SLIM (HE SLIM), External Hex BIOFIT), External Hex SOULFIT (HE SOULFIT), External Hex PROPFIT (HE PROPFIT) and External Hex WAYFIT). The HE implants are bone-level implants. The subject device abutments components mate exclusively with the subject implants of the same line.
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