BEUDAMED
    6 results · 47ms · Sources: EU EUDAMED, US FDA

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    FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth

    FDA Recall
    Open, Classified ·Envisiontec US Llc·Product code EBI·January 6, 2022

    FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth

    FDA Recall
    Open, Classified ·Envisiontec US Llc·Product code EBI·January 6, 2022

    PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.

    FDA Recall
    Open, Classified ·Envisiontec US Llc·Product code EBZ·January 20, 2022

    FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth

    FDA Enforcement
    Class II ·Ongoing·Envisiontec US Llc·February 23, 2022

    PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.

    FDA Enforcement
    Class II ·Ongoing·Envisiontec US Llc·March 16, 2022

    FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth

    FDA Enforcement
    Class II ·Ongoing·Envisiontec US Llc·February 23, 2022