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Lower risk Medical device recall · FDA · Published January 20, 2022

Envisiontec PCA 4000 Curing Units May Not Cure Dental Resins Properly

Envisiontec recalls PCA 4000 curing units (SKU ACC-06-1000) that may not fully cure dental resins to specifications. Affected units sold to dental professionals.

🇺🇸 FDA recall #Z-0746-2022Medical deviceEnvisiontec ›
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Recalling firmEnvisiontec US Llc15162 S Commerce Dr · Dearborn, MI 48120-1237
✎ GovInfoNow plain-language explainer

What happened, in plain English

Envisiontec is recalling PCA 4000 curing units that may not properly cure dental resins. This could lead to dental restorations not meeting expected strength or durability. Read more at govinfonow.com/recall/61235-envisiontec-pca-4000-curing-units-may-not-cure-dental-resins.

Source Summary by GovInfoNow · govinfonow.com/recall/61235-envisiontec-pca-4000-curing-units-may-not-cure-dental-resins · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0746-2022

Cite this page

“Envisiontec PCA 4000 Curing Units May Not Cure Dental Resins Properly.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61235-envisiontec-pca-4000-curing-units-may-not-cure-dental-resins. Based on FDA recall #Z-0746-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0746-2022%22&limit=1).

Why it’s dangerous

The PCA 4000 may not fully cure dental resins to the required specifications. This could result in dental restorations that are weaker than intended, potentially affecting long-term durability.

Who’s affected

Dental professionals who purchased PCA 4000 curing units with SKU ACC-06-1000. The recall does not affect industrial customers.

How to tell if you have this one

Check for PCA 4000 curing units with SKU number ACC-06-1000. The recall applies only to dental customers, not industrial customers.

  • Brand
    Envisiontec
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify if your PCA 4000 unit has SKU number ACC-06-1000.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 55 days after the firm started it.

1. Firm started the recall: Jan 20, 202212. FDA classified it Class II: Mar 10, 202223. Published in FDA’s Enforcement Report: Mar 16, 202232022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0746-2022 (January 20, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0746-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA