Recall Z-0665-2018— Ivoclar Vivadent, Inc.

Name: FDA recall Z-0665-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-03

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 110/A1, Product code 541501AN, Catalog number 541501. 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 record

K884588 — HELIOMOLAR(R) DENTAL RESTORATIVEWilliams Dental Co., Inc.·cleared 1989-01-27

K-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 110/A1, Product code 541501AN, Catalog number 541501

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.