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510(k) Data Aggregation

    K Number
    K251626

    Validate with FDA (Live)

    Date Cleared
    2025-11-03

    (159 days)

    Product Code
    Regulation Number
    872.6640
    Panel
    Dental
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Midmark Dental Delivery Systems are intended to provide dental professionals with low voltage electric, air, and water to operate dental handpieces, syringes, and accessories during dental examinations and procedures.

    Midmark Assistant's Delivery Systems are intended to provide dental professionals with air, water, and suction to operate dental handpieces, syringes, and accessories during dental examinations and procedures.

    Device Description

    The Midmark Dental Delivery System encompasses two types of dental units: Dental Delivery Systems and Assistant's Delivery Systems.

    The Dental Delivery System is a workstation for the dental clinical space that provides air, water and electrical power for the operation of dental instruments. The system has two models with three mounting options that can provide instrument positioning for right-handed and left-handed clinicians practicing to the patient's side or for clinicians practicing at the 12 o'clock position. The DS-1100-001 model mounts to the base of the Midmark Dental Chair. This model has a combination of swing arms and a flex arm providing both horizontal and vertical positioning of the delivery unit. The DS-1200-001 model mounts to a cabinet or column base and also includes an Assistant's Delivery System. The cabinet mount has a combination of swing arms providing horizontal positioning of the delivery unit to either side of a clinician practicing behind the patient at the 12 o'clock position. The adjustable column mount option that connects to a cabinet adds vertical positioning adjustment to the DS-1200-001.

    The Dental Delivery System contains an air and water control manifold designed to route coolant air, drive air, and water to the active dental handpiece. This manifold consists of a pneumatically actuated diaphragm mechanism and an integrated air and water distribution block. When handpieces are docked in their respective instrument holders, air pressure in the handpiece line applies force to the diaphragm within the manifold, closing the associated air ports and preventing air and water flow. When a handpiece is undocked from its holder, a valve within the holder releases the air pressure against the diaphragm. When the foot control is activated, drive and coolant air pressures overcome the diaphragm, opening the previously closed air port. The foot control activation simultaneously sends a pneumatic signal to open the corresponding water valve within the manifold assembly. As a result, the drive air, coolant air, and coolant water are able to flow through the distribution pathways to the undocked handpiece. Returning the handpiece to its holder triggers the holder's valve mechanism to re-pressurize the diaphragm, re-closing the air and water distribution pathways.

    The Assistant's Delivery System is a workstation for the dental clinical space that provides air, water, and vacuum for the operation of dental instruments. The ADS-1100-001 model mounts to the head end of the Midmark Dental Chair. A junction box located at the foot end of the chair base provides a contained space for the connection of the Assistant's Delivery System to air, water, and vacuum sources. The ADS-1200-001 mounts to a Midmark cabinet base. The DS-1200-001 Assistant's Delivery System mounts on a movable arm which is common to the Dental Delivery System. The Assistant's Delivery System mounts to the lower side of its supporting arm and the Dental Delivery System mounts to the upper side of the arm allowing both to pivot independently for positioning of the instruments to the clinician. The cabinetry base has a space for the connection of the Assistant's Delivery System to air, water, and vacuum sources.

    AI/ML Overview

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