Envisiontec US Llc FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recaClass IIJan 20, 2022The PCA 4000 may not fully cure EnvisionTEC dental resins to	The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.	Class IIDevices	Jan 20, 2022
FLEXCERA SMILE -a Dental resins for the fabrication of artificial teethClass IIJan 6, 2022Manufactured in a non-FDA-registered manufacturing facility	Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin	Class IIDevices	Jan 6, 2022
FLEXCERA BASE -a Dental resins for the fabrication of artificial teethClass IIJan 6, 2022Manufactured in a non-FDA-registered manufacturing facility	Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin	Class IIDevices	Jan 6, 2022