Envisiontec FLEXCERA SMILE Dental Resins Recalled for Non-FDA Manufacturing
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.
Lower-risk recall
Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/61312-envisiontec-flexcera-smile-dental-resins-recalled-for-non-fda-manufacturing.
Source Summary by GovInfoNow · govinfonow.com/recall/61312-envisiontec-flexcera-smile-dental-resins-recalled-for-non-fda-manufacturing · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0643-2022
Cite this page
“Envisiontec FLEXCERA SMILE Dental Resins Recalled for Non-FDA Manufacturing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61312-envisiontec-flexcera-smile-dental-resins-recalled-for-non-fda-manufacturing. Based on FDA recall #Z-0643-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0643-2022%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Envisiontec- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide distribution.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0642-2022 | FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth; Manufactured from April 1, 2021 to September 15, 2021. 120421-a 70921 30521 180621d 010421 140621a 060721a 120421-b 270521 130521a 090721a 060421-a 140621b 060721b 120421-c 030621 130521b 090721b 060421-b 140621c 060721c 220421-a 160721a 130521c 130721a 060421-c 150621a 060721d 220421-b 160721b 200521a 130721b 080421-a 150621b 070721a 220421-c 180721 200521b 130721c 080421-b 150621c 070721b 230621a 280721 200521c 130721d 080421-c 210621a 070721c 230621b 290721 250521a 300821a 130421-a 210621b 070721d 230621c 100821 250521b 300821b 130421-b 210621c 080721a 230621d 100821 250521c 310821a 130421-c 210621d 080721b 170721a 090621c 310521a 210721a 200421-a 220621a 080721c 170721b 180721a 310521b 210721b 200421-b 220621b 080721d 190721 180721b 310521c 210721c 200421-c 220621c 120721a 290721a 180721c 070621a 40821 260421-a 220621d 120721b 290721b 180721d 070621b 60821 260421-b 300621a 120721c 290721c 190721a 070621c 130821 260421-c 300621b 120721d 90821 190721b 110621a 090921-2 270421-a 300621c 140721a 110821 160821 110621b 100921 270421-b 300621d 140721b 120821 270821 110621c 140921-1 270421-c 050721a 140721c 190821 190421a 180621a 140921-2 030521 050721b 140721d 230821 190421b 190621b 140921-3 040521a 050721c 150721a 240821 190421c 180621c 140921-4 040521b 050721d 200721a 070421-a 210421-a 260521a 290621a 040521c 310821b 200721b 070421-b 210421-b 260521b 290621b 170521a 010921a 200721c 070421-c 210421-c 160621a 290621c 170521b 010921b 200721d 170821 280721a 160621b 290621d 170521c 020921a 300721a 180821 280721b 160621c 280621a 180521a 020921b 300721b 110521 280721c 160621d 280621b 180521b 030921a 300721c 200821 030821a 170721 280621c 180521c 030921b 50821 020621 030821b 140421-b 280621d 190521a 070921 200421 030821c 140421-a 020821a 090621a 080921 250821 130921-1 180821b 020821b 090621b 080921-2 260821 130921-2 100921-2 020821c 090921 140421-c | 574 units |
| Z-0643-2022 | FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth; Manufactured from April 1, 2021 to September 15, 2021. Lot Numbers: 120421-a 70921 30521 180621d 010421 140621a 060721a 120421-b 270521 130521a 090721a 060421-a 140621b 060721b 120421-c 030621 130521b 090721b 060421-b 140621c 060721c 220421-a 160721a 130521c 130721a 060421-c 150621a 060721d 220421-b 160721b 200521a 130721b 080421-a 150621b 070721a 220421-c 180721 200521b 130721c 080421-b 150621c 070721b 230621a 280721 200521c 130721d 080421-c 210621a 070721c 230621b 290721 250521a 300821a 130421-a 210621b 070721d 230621c 100821 250521b 300821b 130421-b 210621c 080721a 230621d 100821 250521c 310821a 130421-c 210621d 080721b 170721a 090621c 310521a 210721a 200421-a 220621a 080721c 170721b 180721a 310521b 210721b 200421-b 220621b 080721d 190721 180721b 310521c 210721c 200421-c 220621c 120721a 290721a 180721c 070621a 40821 260421-a 220621d 120721b 290721b 180721d 070621b 60821 260421-b 300621a 120721c 290721c 190721a 070621c 130821 260421-c 300621b 120721d 90821 190721b 110621a 090921-2 270421-a 300621c 140721a 110821 160821 110621b 100921 270421-b 300621d 140721b 120821 270821 110621c 140921-1 270421-c 050721a 140721c 190821 190421a 180621a 140921-2 030521 050721b 140721d 230821 190421b 190621b 140921-3 040521a 050721c 150721a 240821 190421c 180621c 140921-4 040521b 050721d 200721a 070421-a 210421-a 260521a 290621a 040521c 310821b 200721b 070421-b 210421-b 260521b 290621b 170521a 010921a 200721c 070421-c 210421-c 160621a 290621c 170521b 010921b 200721d 170821 280721a 160621b 290621d 170521c 020921a 300721a 180821 280721b 160621c 280621a 180521a 020921b 300721b 110521 280721c 160621d 280621b 180521b 030921a 300721c 200821 030821a 170721 280621c 180521c 030921b 50821 020621 030821b 140421-b 280621d 190521a 070921 200421 030821c 140421-a 020821a 090621a 080921 250821 130921-1 180821b 020821b 090621b 080921-2 260821 130921-2 100921-2 020821c 090921 140421-c | 795 units |
What to do — step by step
Check Product Label
Look for lot numbers on the FLEXCERA SMILE dental resin packaging, such as 120421-a or 70921.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 48 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-0643-2022 (January 6, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0643-2022 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.