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510(k) Data Aggregation

    K Number
    K242404
    Device Name
    BDC Dental Unit
    Manufacturer
    BDC Dental Corporation Ltd.
    Date Cleared
    2025-02-07

    (178 days)

    Product Code
    EIA, KLC
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    BDC Dental Corporation Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BDC Dental Unit is intended to supply power to and serve as a base for dental devices and accessories. This device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.
    Device Description
    The BDC dental unit is intended to supply air, water, vacuum and electrical power to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory. The BDC dental unit consists of a patient chair, dentist element (tray table), assistant element (3-way syringe, high volume evacuator and saliva ejector), side cabinet support center, foot control, cuspidor and a dental operating light, which for patient to sit during the dental diagnosis, treatment and/or operation.
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    K Number
    K203425
    Device Name
    Surgical Mask
    Manufacturer
    BDC Dental Corporation Ltd.
    Date Cleared
    2021-03-05

    (105 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    BDC Dental Corporation Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The surgical masks are intended to be worn by personnel during medical and surgical procedures to protect both the patient and the operating personnel from transfer of microorganisms, body fluids and particulate material. The mask is a single use, disposable device, provided non-sterile.
    Device Description
    The Surgical Masks, Model IIR, are non-sterile, single use, three-layers, flat-pleated style with ear loop and nose piece. - The inner and outer layers of the Surgical Mask are made of Non-woven Spunbond . Polypropylene for protection against fluid penetration that will not lint, teat or shred. - . The middle layer is made of highest quality Melt Blown Polypropylene Filter for optimal filtration and breathability, meeting ASTM Level 3 performance requirements. - . The sonically sealed ear loops are made of Polyester and Spandex to secure the mask over the user's face and mouth. They fit loosely and are attached to the mask to eliminate irritation. - The adjustable nose piece is made of Aluminum forms strong seal for protection. . - The Surgical Masks will be provided in Blue. The device is not made from any natural rubber latex.
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