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510(k) Data Aggregation

    K Number
    K213890
    Device Name
    IMICRYL Impression Materials
    Date Cleared
    2022-02-11

    (60 days)

    Product Code
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMICRYL Dis Malzemeleri San. Ve Tic. A.S.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    PUTTY SOFT is to be used as preliminary materials for: -Two-step Putty-wash impression technique -One-step Putty-wash impression technique HEAVY BODY materials for: -One-step impression technique (simultaneous technique) using single or dual viscosities -Two-step impression technique using dual viscosities -Functional impression MEDIUM/MONOPHASE/REGULAR BODY tray or syringeable impression material for: -Taking impressions over fixed/removable restorations and implants (i.e., transferring impression posts and bridge components) -Functional impressions -Fabricating crown and bridgework or inlays -Fabricating full or partial dentures -Reline impressions -Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques -Transferring root posts when fabricating posts and cores indirectly LIGHT BODY is to be used as syringeable impression materials for: -Two-step putty-wash impression technique -One-step putty-wash impression technique -Two-step impression technique using dual viscosities -Reline impressions -Fabricating full or partial dentures EXTRA LIGHT BODY is to be used as syringeable impression materials for: -Two-step putty-wash impression technique -One-step putty-wash impression technique -Two-step impression technique using dual viscosities -Reline impressions -Fabricating full or partial dentures BITE REGISTRATION is used for impression as below. -Taking occlusal surfaces -Confirming occlusal surfaces -Recording after putting the articulator
    Device Description
    The IMICRYL family of silicone impression materials: includes the brand names SPIRIAS, NICETY, REFLECT and PE Sil. It is used by dentists to obtain anatomical data of the patient's mouth and then to obtain a useful plaster cast to diagnose problems, identify necessary interventions and/or check their effectiveness. They are elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy and resistance to permanent deformation, cured by addition reaction. The IMICRYL family of silicone impression materials consists of six different viscosities (putty soft, heavy body, medium/monophase/regular body, light body, extra light body, bite registration) for various application systems. Putty Soft consists of 1:1 250 and 1:1 300 mL jars, other consistencies 1:1 50 mL syringes. Although the consistency and composition of medium, monophase and regular body products, which have type 2 consistency, are exactly the same, they are offered for sale under three different names.
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