FDA Device recall Z-0213-2016
Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar…
- FDA Device
- Class II
- terminated
- Published 2015-11-11
On 2015-11-11 the FDA classified a Class II recall of Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar… by Ivoclar A G, citing A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty component seem to be larger than the size defined in the formula. This results in d….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0213-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-07 |
| Published | 2015-11-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ivoclar A G |
| Distribution | US |
Product
Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and foramina caeca.
Reason
A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty component seem to be larger than the size defined in the formula. This results in difficulties during extrusion of the material.
Identifiers
| code_info | Lot U12511, Kit Lot U19925 (Helioseal F Assortment only), exp. 11.09.2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0213-2016%22
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