Recall Z-2373-2016— Ivoclar Vivadent, Inc.
Class II · Terminated
Class II FDA medical device recall by Ivoclar Vivadent, Inc., initiated 2016-07-11, terminated 2017-09-22. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Ivoclar Vivadent, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-07-11
- Terminated
- 2017-09-22
- Firm location
- Amherst, NY, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.