BEUDAMED
    3 results · 12ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718

    FDA Enforcement
    Class II ·Ongoing·Keystone Industries·September 20, 2023

    Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect against penetration of amalgam into the dentina Item No. 0921526

    FDA Enforcement
    Class II ·Ongoing·Keystone Industries·September 20, 2023

    KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011

    FDA Enforcement
    Class II ·Ongoing·Keystone Industries·January 10, 2024