Device 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.
Z-0213-2016
Product summary
- Firm
- Ivoclar A. G.
- Event
- Event 72290
- Status
- Terminated
- Classification
- Class II
- Quantity
- Domestic: 337 units
- Official record key
device-enforcement:Z-0213-2016
Official wording
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.
Code information: Lot U12511, Kit Lot U19925 (Helioseal F Assortment only), exp. 11.09.2017
Distribution pattern: Nationwide Distribution including NJ, PA, SC, FL, IN, IA, WI, IL, MO, TX, CA and WA.
Derived failure modes
-
Manufacturing or process control
defect occurred in the production