Reported Mar 16, 2022 · Ongoing

PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall…

Envisiontec US LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Envisiontec US Llc · 15162 S Commerce Dr · Dearborn, MI · 48120-1237

Is this the product you have?

  • 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.
Lot codes and dates
  • All units SKU number ACC-06-1000
Amount recalled
172 units

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:51 PM UTC

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