FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth recalled over labeling errors
- Recall date
- January 6, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Envisiontec US Llc recalls FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth
- Recall number
- Z-0642-2022
- FDA classification
- Class II
- Brand / firm
- Envisiontec US Llc
- Sold / distributed
- US Nationwide distribution.
Why it was recalled
Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth
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