FDAJanuary 20, 2022device
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 recall recorded by the U.S. Food & Drug Administration.
The hazard
The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.
What to do
FDA enforcement status: Ongoing
Brands named
envisiontec
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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