Envisiontec recalls FLEXCERA SMILE dental resins made between April 2021 and September 2021 due to being produced in a non-FDA-registered facility and mislabeled as German. Affected products have specific lot numbers.
Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin
Envisiontec is recalling FLEXCERA SMILE dental resins made from April 1, 2021 to September 15, 2021 because they were manufactured in a non-FDA-registered facility and incorrectly labeled as German products. This recall affects dental professionals and patients using these resins for artificial teeth.
The resins were made in a facility not registered with the FDA and were mislabeled as German products. This could lead to potential quality issues or safety concerns if the product is used in dental procedures.
Dental professionals and patients who purchased FLEXCERA SMILE dental resins between April 1, 2021 and September 15, 2021. Those using the product for artificial teeth fabrication are most at risk.
Check the product label for lot numbers listed in the recall (e.g., 120421-a, 70921, 30521). Products were sold between April 1, 2021 and September 15, 2021.
Look for lot numbers on the FLEXCERA SMILE dental resin packaging, such as 120421-a or 70921.
The FLEXCERA SMILE dental resins were manufactured in a non-FDA-registered facility and mislabeled as German products.
Check the product label for lot numbers listed in the recall. If you have a matching lot number, contact Envisiontec for further instructions.
The recall is due to manufacturing and labeling issues, but no specific safety risks are mentioned in the official notice.
We’ve drafted a message you can send Envisiontec to request your refund or repair — edit it as you like.
Subject: Recall Z-0643-2022 — Envisiontec Envisiontec Hello, I own a Envisiontec that is covered by recall Z-0643-2022 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.
