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510(k) Data Aggregation

    K Number
    K253315

    Validate with FDA (Live)

    Date Cleared
    2026-01-22

    (114 days)

    Product Code
    Regulation Number
    872.3630
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Straumann Variobase Abutments XC for Bridge/Bar are prosthetic components placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann Variobase Abutments XC for Bridge/Bar are indicated for screw-retained or cement-retained bridge restorations. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize, and shape the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion. Final abutments and restorations may be placed in occlusion when the implant is fully osseointegrated.

    Device Description

    Straumann Variobase Abutments XC for Bars and Bridges are intended to be placed into Straumann implants to provide support for multi-unit restorations.

    The prosthetic restoration (bar/bridge) must be cemented onto the Variobase abutments, which is then screwed onto the implants. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.

    The subject Variobase abutments are manufactured from Ti-6Al-7Nb (TAN) and are anodized in violet.

    The Variobase Abutments for bar/bridges are non-engaging devices intended to support multiple-unit restorations.

    The Variobase abutments are provided non-sterile with instructions for end user steam sterilization. The Variobase abutments are fixed in the implant by means of a basal screw which is also manufactured from Ti-6Al-7Nb (TAN). The subject Straumann Variobase Abutments XC for Bridge/Bar is provided in two different platform models, both available with straight and angled screw channel solutions:

    Table 10.4.a - Straumann Variobase Abutments XC for Bridge/Bar characteristics

    PlatformØ (mm)Gingival heights (mm)Chimney height (mm)
    RB/WB3.8 / 4.51.5 / 2.5 / 3.57
    WB5.50.75 / 1.57
    AI/ML Overview

    N/A

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