Recall Z-0668-2018— Ivoclar Vivadent, Inc.
Class III · Terminated
Class III FDA medical device recall by Ivoclar Vivadent, Inc., initiated 2017-08-03, terminated 2018-08-28. It names one FDA 510(k) clearance: K884588. Product: Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559. Reason: Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring..
- Recalling firm
- Ivoclar Vivadent, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2017-08-03
- Terminated
- 2018-08-28
- Firm location
- Amherst, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559
Reason for recall
Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.
Data sourced from openFDA. This site is unofficial and independent of the FDA.