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510(k) Data Aggregation

    K Number
    K203824
    Device Name
    VPS Impression Material
    Manufacturer
    Date Cleared
    2021-04-19

    (111 days)

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

    Hygedent INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    VPS Impression Material(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;
    Device Description
    K203824:VPS Impression Material is dental Impression Material. It complies with the requirements of ISO 4823:2015 for dental elastomeric impression materials. It is supplied as atwo-part base/catalyst formulation preloaded in a dual-barrel cartridge. The VPS Impression Material package includes four dual-barrel 50ml cartridges.
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    K Number
    K191034
    Device Name
    VPS Impression Material
    Manufacturer
    Date Cleared
    2019-09-04

    (139 days)

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

    Hygedent Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    VPS Impression Material is intended for use with all crowns, bridges, occlusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums.
    Device Description
    VPS Impression Material is dental Impression Material. It complies with the requirements of ISO 4823:2015 for dental elastomeric impression materials. It is supplied as a two-part base/catalyst formulation preloaded in a dual-barrel cartridge. The VPS Impression Material package includes four dual-barrel 50ml cartridges.
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    K Number
    K170812
    Device Name
    HygePLUS Alginate Impression Material
    Manufacturer
    Date Cleared
    2017-07-26

    (131 days)

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

    HYGEDENT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HygePLUS Alginate Impression Material is irreversible hydrocolloids for dental Impressions used by the dentist to take the anatomical data of the patient's mouth. The device is Intended to provide models for study and for production of restorative prosthetic devices, such as gold Inlays and dentures.
    Device Description
    HygePLUS Alginate Impression Material is a alginate impression material for general dental practice and for orthodontics. It is presented in the form of a homogeneous yellow powder with spearmint flavour.
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