Z-2373-2016Class II

OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small...

Name: Z-2373-2016 OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small...
Creator: Ivoclar Vivadent, Inc.
Published: 2016-07-11
License: https://open.fda.gov/license/

Ivoclar Vivadent, Inc. / initiated 2016-07-11 / Terminated

FDA source

Ivoclar Vivadent, Inc. began a recall of OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment... on 2016-07-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2373-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-11
Posted: 2016-08-09
Terminated: 2017-09-22
Recalling firm: Ivoclar Vivadent, Inc.
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.
Product code: EHJ Disk, Abrasive
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.
FDA root cause: Under Investigation by firm
Action: URGENT MEDICAL DEVICE RECALL Letter (dated 7/11/2016) and Response Form were sent to customers on 7/11/2016 via Certified Mail, Return Receipt, Requested. The letter instructs customers to notify their customers of the recall if the product had been distributed and to return the product to Ivoclar Vivadent. For questions, please contact Ivoclar Vivadent Customer Service at 1-800-533-6825.
Quantity in commerce: US: 86 units total
Distribution: Distributed in the states of CA, FL, GA, IA, IL, IN, KS, KY, MA, MI, NV, NY, OH, PA, TX, and WA.
Product codes and lots: REF/Product ID 634459: Lot UL0843; REF/Product ID 634458: Lot VL0704; REF/Product ID 634464: Lot VL0705.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2373-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2373-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-09

Product code EHJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)