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510(k) Data Aggregation

    K Number
    K190406
    Device Name
    SDS2.2 dental implant
    Manufacturer
    SDS Swiss Dental Solutions AG
    Date Cleared
    2020-02-20

    (364 days)

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

    SDS Swiss Dental Solutions AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SDS2.2 dental implants are intended as artificial replacements to be placed in the human upper or lower jaw to provide anchor points for the prosthetic restoration. They are indicated for transgingival healing. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. SDS2.2 standard implant posts and SDS2.2 standard screws are industrially manufactured prosthetic components. They are connected to the SDS2.2 dental implant and enable the fixation of prosthetic restorations.
    Device Description
    SDS2.2 dental implants are a two-piece implant system to fit a synthetic root replacement into the human jaw. The implants are made of Y-TZP (yttria-stabilized tetragonal zirconia poly-crystal) zirconium dioxide ceramics in accordance with ISO 13356. The SDS2.2 dental implant system with its included components is used to fix the prosthetic restoration and is suitable for patients with an intolerance to metal. The implants have a self-tapping Dynamic Thread® in the implant for good primary stability. Its bone-condensing section has a 2.5x thread depth. The upper section of the implant has a micro-thread. The outer surface of the SDS2.2 implants is abrasive blasted for good osseointegration, the implant shoulder is machined. SDS2.2 implants are provided in different length/ diameter combinations and with 2 different shoulder designs (standard shoulder and oval shoulder). The implants are provided sterile in sterile packaging and are intended for single use. The sterile packaging also includes the SDS2.2 cover screw made of PEEK (Polyetheretherketone), which can be used to protect the implant interface during the healing phase up to 180 days. SDS2.2 standard implant posts are made of Y-TZP and are attached to SDS 2.2 dental implants by cementation. During cementation, the implant posts are screw retained with the SDS2.2 standard PEEK screw to ensure implant post is fixed at final position. The SDS2.2 standard PEEK screw is removed before the cement is completely cured. After attachment to the SDS2.2 implant, standard implant posts enable cementation of prosthetic restorations. SDS2.2 standard implant posts are available in different designs. The SDS2.2 standard implant posts and SDS2.2 standard PEEK screws are provided non-sterile.
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    K Number
    K181953
    Device Name
    SDS1.2 dental implant
    Manufacturer
    SDS Swiss Dental Solutions AG
    Date Cleared
    2019-11-20

    (485 days)

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

    SDS Swiss Dental Solutions AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SDS 1.2 dental implants are intended as artificial replacements to be placed in the human upper or lower jaw to provide anchor points for the prosthetic restoration. They are indicated for transgingival healing. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. SDS1.2_33xx implants are recommended as single-tooth implant for upper lateral and lower incisors for fixed prosthetic restorations only. SDS 1.2 healing caps-disc, SDS .2 temporary caps and SDS 1.2 standard screws are industrially manufactured prosthetic components. They are connected to the SDS1.2 dental implant and enable the production/ fixation of long-term temporary restorations or protect the implant during healing phase for up to 180 days.
    Device Description
    SDS1.2 dental implants are a one-piece implant system to fit a synthetic root replacement into the human jaw. The implants are made of Y-TZP (yttria-stabilized tetragonal zirconia poly-crystal) zirconium dioxide ceramics in accordance with ISO 13356. The SDS1.2 dental implants are used to fix the prosthetic restoration and are suitable for patients with an intolerance to metal. The implants have a self-tapping Dynamic Thread® in the implant for good primary stability. Its bone-condensing section has a 2.5x thread depth. The upper section of the implant has a micro-thread. The outer surface of the SDS1.2 implants is abrasive blasted for good osseointegration, the implant shoulder is machined. SDS1.2 implants are provided in different length/ diameter combinations and with 2 different shoulder designs. The implants are provided sterile in sterile packaging and are intended for single use. SDS1.2 dental implants must not be re-sterilized or disinfected either. When delivered, all SDS1.2 dental implants are mounted with the disposable SDS1.2 insertion tool. Temporary restorations can be produced either individually or by using the prefabricated SDS1.2 Temporary cap as basis. The SDS1.2 Temporary caps are made of PEEK (polyether ether ketone). The SDS1.2 Temporary cap may only be used for screw-retaining temporary restorations with SDS1.2 standard screw (SDS1.2_SS-T) and must not be cemented. The SDS1.2 Temporary caps are provided non-sterile and must be cleaned, disinfected and sterilized according to the instructions given in the "Instructions for use" document. They are intended for single-use and can stay for a maximum period of 180 days in situ. SDS1.2 Healing caps-disc may be used to protect the dental implant. The Healing caps-disc are made of Y-TZP (yttria-stabilized tetragonal zirconia poly-crystal) zirconium dioxide ceramics in accordance with ISO 13356. They can be fixed by screw-retaining with SDS1.2 standard titanium screws. The SDS1.2 Healing caps-disc are provided non-sterile and must be cleaned, disinfected and sterilized according to the instructions given in the "Instructions for use" document. They are intended for single-use and can stay for a maximum period of 180 days in situ.
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