International Medical Devices Database

Manufacturer Address
Ivoclar A. G., Fl-9494, Schaan Liechtenstein
Manufacturer Parent Company (2017)
Ivoclar Vivadent Aktiengesellschaft
Source
USFDA
1 Event
- Recall of Helioseal F Sealant

One device in the database

Helioseal F Sealant

Model / Serial
Lot U12511, Kit Lot U19925 (Helioseal F Assortment only), exp. 11.09.2017
Product Classification
Dental Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution including NJ, PA, SC, FL, IN, IA, WI, IL, MO, TX, CA and WA.
Product Description
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.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Ivoclar A. G.

One device in the database

Helioseal F Sealant