Recall Z-1026-2016— Ivoclar Vivadent, Inc.

Name: FDA recall Z-1026-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-12

Class II · Terminated

Class II FDA medical device recall by Ivoclar Vivadent, Inc., initiated 2016-02-12, terminated 2017-05-08. It names one FDA 510(k) clearance: K813015. Product: Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant. Reason: Complaints were received claiming the material failed to polymerize under the curing light. After investigation, it was determined that a wrong photo-initiator was used in the production batch U30755 of Helioseal Clear. This failure can lead to incomplete curing of the sealant, if mono-wave LED curing lights are used..

Recalling firm: Ivoclar Vivadent, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-02-12
Terminated: 2017-05-08
Firm location: Buffalo, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K813015 — HELIOSEALVivadent (Usa), Inc.·cleared 1981-12-02

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

Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant

Reason for recall

Complaints were received claiming the material failed to polymerize under the curing light. After investigation, it was determined that a wrong photo-initiator was used in the production batch U30755 of Helioseal Clear. This failure can lead to incomplete curing of the sealant, if mono-wave LED curing lights are used.

Data sourced from openFDA. This site is unofficial and independent of the FDA.