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510(k) Data Aggregation

    K Number
    K040951
    Device Name
    SR ADORO
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2004-05-19

    (37 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For Metal Supported restorations with conventional cementation
    For Metal Supported restorations using SR Adoro Thermo Guard

    • Veneering of metal supported restorations using SR Adoro Thermon CRA Adoro
    • Veneering of metal supported restorations using ON Pincho Station Thermo Guard
    • Veneering of combined dentures (e.g. telescope veneers) using SFA Adoro Thermo Guard
    • Veneering of combined dentares (e.g. Ichoope veng SR Adoro Thermo Guardina
      Veneering of partially removable implant superstructures using SPAArco
    • Veneering of partially removable implant superstructures using SF Adoro Themo Guard Guard
    • Fabrication of Iong-term temporaries using SR Adoro Thermo Guard
    • Fabrication of forig-tenn tomporanes with SR Adoro Opaquer Pink.
      For Metal-Free restorations
      With Adhesive Cementation:
    • Inlays/Onlays/Veneers
    • Anterior crowns without Vectris framework
    • Anterior orowns with Vectrist framework
    • Antenor and posterior Crowns was will Wectris framework
    • 3-unit antenor and positis framework
      With Conventional Cementation :
      Conventional Cementation .
    • long-term temporaries with Vectris framework for a maximum duration of wear of 12 months.
    • For removable prosthetics
      For removable prostnetics
    • Surface characterization of Ivoclar Vivadent denture teeth with SR Adoro Stains. Surfaces must subsequently be covered with SR Adolo layering material.
    • Surface characterization with SR Adoro layering material.
    • Shade and shape modifications of Ivociar Vivadent denture teeth with SR Adoro layering material in conjuction with SR Composiv.
    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental device called "SR Adoro®". It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and lists its intended uses and contraindications.

    Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study from the provided text.

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