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510(k) Data Aggregation

    K Number
    K201184
    Device Name
    Lascod Impression Materials
    Manufacturer
    Lascod Spa
    Date Cleared
    2020-05-05

    (4 days)

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

    Lascod Spa

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lascod family of silicone impression materials includes the brand names: Ghenesyl, Kromopan Sil are used by dentists to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define required interventions, and/or check their effectiveness. The Ghenesyl Putty and Kromopan Sil Putty products are indicated for obtaining preliminary impressions for the two-step putty/wash and base for the sandwich technique. The impression can be electroplated. The Ghenesyl Body and Kromopan Sil Body products are indicated for the two-step putty/wash and for the sandwich technique. The impression can be electroplated. The Ghenesyl Mono and Kromopan Sil mono products are indicated for monophasic technique, though it can be used also with Super Light Body / Light Body / Regular Body wash silicones as support material inside individual impression tray or standard stainless-steel impression tray. Kromopan Sil Bite and Oklurest used by dentists to take impressions of occlusal surfaces in order to confirm the occlusal surfaces onto the plaster models assembled on an articulator. Kromopan Sil Bite and Oklurest and products are indicated for orthodontic occlusion registration keys for gnathological registrations, inter-maxillary registration keys for centered positions, eruptions and ectopic eruptions, registration for cephalometric analysis which also require subsequent scanning with CAD systems.
    Device Description
    Lascod Impression Materials are addition-curing polyvinylsiloxane silicones. They exhibit excellent accuracy, maximum thixotropy, and hydrophilicity. Additional elastomeric properties include, fast in the mouth setting time, high resistance to tear, dimensional accuracy, and resistance to permanent deformation. The Lascod impression material product line boasts multiple different variants: hard and soft putty; heavy, regular, light and superlight body – all putties and bodies, are available both as normal and fast set; mono and bite. Putties are provided in 300 or 150 ml plastic jars. The body and the bite product lines, are usually offered in the standard (1: 1) 50 ml dual barrel cartridges. The Mono product line is provided in two forms; a standard (1: 1) 50 ml dual cartridge, and a (5: 1) 380 ml, large dual cartridge.
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    K Number
    K121824
    Device Name
    ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2
    Manufacturer
    LASCOD SPA
    Date Cleared
    2012-08-23

    (63 days)

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

    LASCOD SPA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Kromopan type 1 and 2, Alginor type 1, Alginelle type 1, Alginelle type 2 and Millenium alginates are irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define the required interventions and/or check their effectiveness. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.
    Device Description
    Kromopan type 1, Kromopan type 2, Alginor type 1, Alginelle type 1, Alginelle type 2 and Millenium alginates are irreversible hydrocolloids for dental impressions.
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