FDA-Device2016-03-09Class II
Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant
Ivoclar Vivadent, Inc.
Hazard
Complaints were received claiming the material failed to polymerize under the curing light. After investigation, it was determined that a wrong photo-initiator was used in the production batch U30755 of Helioseal Clear. This failure can lead to incomplete curing of the sealant, if mono-wave LED curing lights are used.
Sold states
Nationwide distribution including NY, PA, FL, IN, IA, TX, and CA.
Affected count
Domestic: 406 units
Manufactured in
175 Pineview Dr, N/A, Buffalo, NY, United States
Products
Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1026-2016Don't want to check this manually?
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