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Envisiontec US Recalls
3 recalls on record · February 23, 2022 to March 16, 2022 · Medical Devices
March 16, 2022Medical DevicesFDA
Envisiontec US Llc recalls PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this reca
Hazard: The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.
February 23, 2022Medical DevicesFDA
Envisiontec US Llc recalls FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
Hazard: Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin
February 23, 2022Medical DevicesFDA
Envisiontec US Llc recalls FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth
Hazard: Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin