Envisiontec US Llc

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0746-2022Class IIPCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins aJanuary 20, 2022
Z-0642-2022Class IIFLEXCERA BASE -a Dental resins for the fabrication of artificial teethJanuary 6, 2022
Z-0643-2022Class IIFLEXCERA SMILE -a Dental resins for the fabrication of artificial teethJanuary 6, 2022