FDA-Device2022-02-23Class II
FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
Envisiontec US Llc
Hazard
Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin
Sold states
US Nationwide distribution.
Affected count
795 units
Manufactured in
15162 S Commerce Dr, N/A, Dearborn, MI, United States
Products
FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0643-2022Don't want to check this manually?
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