Devices

Device Recall OptraPol Polishing Discs

Model / Serial
REF/Product ID 634459: Lot UL0843; REF/Product ID 634458: Lot VL0704; REF/Product ID 634464: Lot VL0705.
Product Classification
Dental Devices
Device Class
1
Implanted device?
No
Distribution
Distributed in the states of CA, FL, GA, IA, IL, IN, KS, KY, MA, MI, NV, NY, OH, PA, TX, and WA.
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.
Manufacturer
Ivoclar Vivadent, Inc.
1 Event
- Recall of Device Recall OptraPol Polishing Discs

Manufacturer

Ivoclar Vivadent, Inc.

Manufacturer Address
Ivoclar Vivadent, Inc., 175 Pineview Dr, Amherst NY 14228-2231
Manufacturer Parent Company (2017)
Ivoclar Vivadent Aktiengesellschaft
Source
USFDA

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