FDA-Device2016-08-17Class II
OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and amalgam.
Ivoclar Vivadent, Inc.
Hazard
After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away. OptraPol Small Flame is also affected. Two complaints were filed referring to OptraPol, claiming that the abrasive polishers wear faster than expected.
Sold states
Distributed in the states of CA, FL, GA, IA, IL, IN, KS, KY, MA, MI, NV, NY, OH, PA, TX, and WA.
Affected count
US: 86 units total
Manufactured in
175 Pineview Dr, Amherst, NY, United States
Products
OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and amalgam.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2373-2016Don't want to check this manually?
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