Recall Z-0643-2022— Envisiontec US Llc
Class II · Ongoing
Class II FDA medical device recall by Envisiontec US Llc, initiated 2022-01-06. FDA's recall record names no specific 510(k) clearance for this event. Product: FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth. Reason: Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin.
- Recalling firm
- Envisiontec US Llc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-01-06
- Firm location
- Dearborn, MI, United States
Product description
FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
Reason for recall
Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin
Data sourced from openFDA. This site is unofficial and independent of the FDA.