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U.S. Department of Health and Human Services

Class 2 Device Recall Helioseal F Sealant

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  Class 2 Device Recall Helioseal F Sealant see related information
Date Initiated by Firm October 07, 2015
Date Posted November 04, 2015
Recall Status1 Terminated 3 on June 14, 2016
Recall Number Z-0213-2016
Recall Event ID 72290
510(K)Number K932078  
Product Classification Sealant, pit and fissure, and conditioner - Product Code EBC
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.
Code Information Lot U12511, Kit Lot U19925 (Helioseal F Assortment only), exp. 11.09.2017
Recalling Firm/
Manufacturer		 Ivoclar A. G.
Fl-9494
Schaan Liechtenstein
For Additional Information Contact Ms. Donna Marie Hartnett, Esq.
716-691-2260
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = EBC and Original Applicant = IVOCLAR NORTH AMERICA, INC.
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