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510(k) Data Aggregation

    K Number
    K092814
    Device Name
    STRAUMANN DENTAL ABUTMENTS
    Manufacturer
    STRAUMANN MANUFACTURING, INC.
    Date Cleared
    2009-12-15

    (92 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    STRAUMANN MANUFACTURING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Straumann NC Temporary Abutments are intended for use with the Straumann Dental Implant for temporary restoration of single crowns and bridges. The Straumann NC Temporary Abutments are indicated for use in Straumann NC Bone Level Implants for temporary restorations of single crowns and bridges for up to six months.
    Device Description
    The Straumann Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, permanent and temporary abutments and surgical and prosthetic parts and instruments. The devices covered in this submission are temporary abutments. Abutments are placed on dental implants to provide support for dental restorations. Temporary abutments act as a basis for the fabrication of individual temporary restorations and temporary bridges on Straumann Dental Implants.
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    K Number
    K090260
    Device Name
    MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS
    Manufacturer
    STRAUMANN MANUFACTURING, INC.
    Date Cleared
    2009-02-26

    (23 days)

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

    STRAUMANN MANUFACTURING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bone cutting instruments are intended for use during oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin or screw.
    Device Description
    The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.
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    K Number
    K080239
    Device Name
    P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS
    Manufacturer
    STRAUMANN MANUFACTURING, INC.
    Date Cleared
    2008-04-30

    (90 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    STRAUMANN MANUFACTURING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. The subject abutments are for permanent screw-retained bridges and bar-retained implant-borne dentures. Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months. Copings are intended to serve as a base for multi-unit bar or bridge restorations. Temporary Copings are intended to serve as a base for temporary restorations for up to 6 months.
    Device Description
    The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments. Abutments are placed into dental implants to provide support for prosthetic restorations, copings for bars and bridges are used as a base for bar and bridge constructions, temporary copings support a temporary restoration out of occlusion and protective caps protect the abutment during the healing phase.
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    K Number
    K070478
    Device Name
    P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP)
    Manufacturer
    STRAUMANN MANUFACTURING, INC.
    Date Cleared
    2007-09-20

    (212 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    STRAUMANN MANUFACTURING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RC Temporary Abutment is intended for use with the P.004 dental implant for temporary restoration of single crowns and bridges in the anterior and posterior region for use up to six months. Healing abutments, often referred to as healing caps, are intended to be used with the P.004 dental implant to protect the inner configuration of the implant during the healing process and maintain, stabilize and form the soft tissue during this phase. P.004 RC Temporary Abutment is indicated for use in Straumann P.004 RC Bone Level implants for temporary restorations of single crowns and bridges for up to six months. P.004 Healing Abutment, customizable (cap) is indicated for use in Straumann P.004 RC Bone Level implants to protect the inner configuration of the implant during the healing process. Maintains, stabilizes and forms the soft tissue and should be placed out of occlusion for up to six months.
    Device Description
    The Straumann P.004 Dental Implant System is an integrated system of endosseous bone level dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments. The devices covered in this submission are temporary abutments. The basal portion of the abutments has 4 protrusions diametrically opposed that engage in the 4 grooves of the P.004 implant. The abutments are seated in the implant with a screw which is mounted in the basal portion of the abutment. The abutment is used for cemented and screw-retained restorations. Healing abutments protect the inner configuration of the abutment and contours the soft tissue during the healing phase.
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