Recall Z-0642-2022— Envisiontec US Llc

Name: FDA recall Z-0642-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-06

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 BASE -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 BASE -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.