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 recall…

Recall date

January 20, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0746-2022

FDA classification

Class II

Brand / firm

Envisiontec US Llc

Sold / distributed

US Nationwide

Why it was recalled

The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.