FDA-Device2022-03-16Class II
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.
Envisiontec US Llc
Hazard
The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.
Sold states
US Nationwide
Affected count
172 units
Manufactured in
15162 S Commerce Dr, N/A, Dearborn, MI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0746-2022Don't want to check this manually?
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