FDAJanuary 6, 2022device
FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin
What to do
FDA enforcement status: Ongoing
Brands named
envisiontec
UPCs
11082116082112082127082125082113092112608211309212
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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