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510(k) Data Aggregation

    K Number
    K152383
    Device Name
    Ceramill Zolid FX
    Manufacturer
    Emergo Europe Consulting
    Date Cleared
    2015-09-21

    (28 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Emergo Europe Consulting

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    "Ceramill Zold FX" preshade are blanks made of zirconium oxide (ZrO2) for type II, class 5 dental applications in accordance with DIN EN ISO 6872. They are used for manufacturing permanent and removable prosthetic restorations (e.g., crowns and three-unit bridges to the molar region) using CNC milling machines (e.g., Ceramill Motion).
    Device Description
    Amann Girrbach AG "Ceramill Zolid FX" is an all-ceramic core dental material made of Yttria-Stabilized Zirconium Oxide (zirconia, YSZ). It is provided as a disk shape (U-shape). CAD/CAM fabrication of core material can then be used to produce copings and substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of permanent and removable prosthetic restorations (e.g. crowns and three-unit bridges to the molar region). The material is then fired in an oven to harden the ZrO2. The milling and final oven hardening is completed by the customer (the dental technician).
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    K Number
    K122095
    Device Name
    ICP TRIAGEMANAGER
    Manufacturer
    Emergo Europe Consulting BV
    Date Cleared
    2012-07-26

    (14 days)

    Product Code
    DRG, CLA
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Emergo Europe Consulting BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tunstall icp triagemanager software application allows the caregiver to review patient information and to motivate and provide educational information to the patient. The Tunstall icp triagemanager is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment. Clinical judgment and experience by a caregiver are required to check and interpret the patient information delivered. The Tunstall icp triagemanager is not intended for real-time monitoring, is not an alarm system and may not be used to receive real-time or time-critical data, is not intended for patients requiring direct medical supervision or emergency intervention, and is not intended for direct diagnosis or monitoring.
    Device Description
    The icp triagemanager is a web-based, telehealth remote patient monitoring system application used by trained healthcare personnel to access patient's vitals sign data and patient's answers to health related questions. The icp triagemanager allows healthcare professionals to review patient's information and to provide educational or motivational information to the patients. The software also allows medical personnel to predefine upper and lower limits outside of which communication with caregivers is initiated. The icp triagemanager is not intended for direct diagnosis or monitoring of patient's conditions, nor is it intended for providing automated treatment decisions or to be used as substitute for professional healthcare judgment. The system is not intended for real-time monitoring of time-critical data, nor is it intended for patients requiring direct medical supervision or emergency intervention. The icp triagemanager runs on a standard "off-the-shelf" server hosted by the health care facility and allows caregivers to review patient vital signs on the secure website. The patient's physiological data are measured using standard commercially available medical devices designed for home use. These devices communicate via commercially available hub/gateways compatible with the icp triagemanager software installed on the host server. The hub/gateway systems communicate over a secure internet connection to a secure database on the host server running the icp triagemanager software.
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