Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

OptraPol Polishing Discs Recalled by Ivoclar Vivadent, Inc. Due to After a few seconds of polishing with moderate...

Date: July 11, 2016
Company: Ivoclar Vivadent, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Ivoclar Vivadent, Inc. directly.

Affected 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.

Quantity: US: 86 units total

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 16 states: CA, FL, GA, IL, IN, IA, KS, KY, MA, MI, NV, NY, OH, PA, TX, WA

Affected (16 states)Not affected

About Ivoclar Vivadent, Inc.

Ivoclar Vivadent, Inc. has 34 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report