Envisiontec recalls FLEXCERA BASE dental resins made between April 2021 and September 2021 due to being manufactured in a non-FDA-registered facility and mislabeled as German origin. Affected units include specific batch codes.
Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin
Envisiontec is recalling FLEXCERA BASE dental resins produced from April to September 2021 because they were made in a facility not registered with the FDA and incorrectly labeled as German. This could lead to unsafe dental materials if used without proper quality assurance.
The product was manufactured in a facility not registered with the FDA, which means it may not meet safety standards. Additionally, it was mislabeled as German origin, which could confuse users about the product's authenticity and quality.
Dental professionals and patients who purchased FLEXCERA BASE resins between April 1, 2021 and September 15, 2021. Those using the product for artificial teeth fabrication are most at risk due to potential quality issues.
Check for batch codes listed in the product description, which include specific date ranges from April 1, 2021 to September 15, 2021. The product is a dental resin used for making artificial teeth.
Look for batch codes on the product label that match the date ranges from April 1, 2021 to September 15, 2021 as listed in the recall notice.
The product was manufactured in a non-FDA-registered facility and mislabeled as German origin, which could affect its safety and quality.
Check the batch code on the product label to see if it falls within the date range from April 1, 2021 to September 15, 2021. If it does, contact Envisiontec for further instructions.
The recall is due to manufacturing and labeling issues, not an immediate risk of injury. However, using unverified products could lead to unsafe dental materials.
We’ve drafted a message you can send Envisiontec to request your refund or repair — edit it as you like.
Subject: Recall Z-0642-2022 — Envisiontec Envisiontec Hello, I own a Envisiontec that is covered by recall Z-0642-2022 from Envisiontec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
