FDA-Device2018-02-28Class III
Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559
Ivoclar Vivadent, Inc.
Hazard
Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.
Sold states
US and Canada
Affected count
2 units
Manufactured in
175 Pineview Dr, N/A, Amherst, NY, United States
Products
Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0668-2018Don't want to check this manually?
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