Z-0213-2016Class II

Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF...

Name: 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...
Creator: Ivoclar A. G.
Published: 2015-10-07
License: https://open.fda.gov/license/

Ivoclar Vivadent, Inc. / initiated 2015-10-07 / Terminated / root cause: manufacturing process

FDA source

Ivoclar A. G. began a 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 vivadent clinical... on 2015-10-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0213-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-07
Posted: 2015-11-04
Terminated: 2016-06-14
Recalling firm: Ivoclar Vivadent, Inc.
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.
Product code: EBC Sealant, Pit And Fissure, And Conditioner
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Ivoclar Vivadent sent an Urgent Medical Device Recall Letter dated October 7, 2015, with Response Forms via Certified Mail, Return Receipt Requested. Dealers were also contacted via telephone/e-mail and informed to expect the letter. Dealers are requested to check their stock and return any affected material for credit, plus notify their customers of the recall. For questions, please contact Ivoclar Vivadent Customer Service at 1-800-533-6825.
Quantity in commerce: Domestic: 337 units
Distribution: Nationwide Distribution including NJ, PA, SC, FL, IN, IA, WI, IL, MO, TX, CA and WA.
Product codes and lots: Lot U12511, Kit Lot U19925 (Helioseal F Assortment only), exp. 11.09.2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0213-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0213-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-04

Product code EBC

K932078Class IIHelioseal FIvoclar North America, Inc. / cleared 1993-09-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)