FDA-Device2018-02-28Class III
Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
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
2,153 units
Manufactured in
175 Pineview Dr, N/A, Amherst, NY, United States
Products
Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0665-2018Don't want to check this manually?
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