Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0746-2022 — 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.

U.S. FDA — Device Enforcement · United States · 2022-01-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0746-2022
Date of alert
2022-01-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Envisiontec US Llc
Product category
device
Product type
Devices
Reported risk: The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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