71 results
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38ms
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Sources: EU EUDAMED, US FDA
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.
FDA Enforcement
Class II
·Terminated·Ivoclar A. G.·November 11, 2015
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.
FDA Recall
Terminated
·Ivoclar A. G. Fl-9494 Schaan Liechtenstein·Product code EBC·October 7, 2015
Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant
FDA Recall
Terminated
·Ivoclar Vivadent, Inc.·Product code EBC·February 12, 2016
Ivoclar Vivadent, Inc.
Manufacturer
🇺🇸 United States·1 Importer
Ivoclar Vivadent AG
Manufacturer
🇱🇮 Liechtenstein
IVOCLAR VIVADENT AG
FDA registration
IVOCLAR VIVADENT AG·32 products·🇱🇮 Liechtenstein
IPS E.MAX PRESS LT
FDA Adverse Event
Injury
·IVOCLAR VIVADENT, AG·Product code EIH·September 20, 2017
IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth Article Number: 758439
FDA Recall
Open, Classified
·IVOCLAR VIVADENT AG BEDERSRASSE LIECHTSTEIN Germany·Product code EIH·April 5, 2024
IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758441
FDA Recall
Open, Classified
·IVOCLAR VIVADENT AG BEDERSRASSE LIECHTSTEIN Germany·Product code EIH·April 5, 2024
IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758434
FDA Recall
Open, Classified
·IVOCLAR VIVADENT AG BEDERSRASSE LIECHTSTEIN Germany·Product code EIH·April 5, 2024
IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758437
FDA Recall
Open, Classified
·IVOCLAR VIVADENT AG BEDERSRASSE LIECHTSTEIN Germany·Product code EIH·April 5, 2024
IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758443
FDA Recall
Open, Classified
·IVOCLAR VIVADENT AG BEDERSRASSE LIECHTSTEIN Germany·Product code EIH·April 5, 2024
IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438
FDA Recall
Open, Classified
·IVOCLAR VIVADENT AG BEDERSRASSE LIECHTSTEIN Germany·Product code EIH·April 5, 2024
IPS E.MAX CAD
FDA Adverse Event
Malfunction
·IVOCLAR VIVADENT AG·Product code NHA·October 20, 2014
VARIOLINK II
FDA Adverse Event
Other
·IVOCLAR VIVADENT AG·Product code EBF·November 1, 2010
MULTILINK AUTOMIX
FDA Adverse Event
Other
·IVOCLAR VIVADENT, AG·Product code EMA·November 16, 2010
IVOCAP PREFERENCE
FDA Adverse Event
Injury
·IVOCLAR VIVADENT AG·Product code EBI·December 18, 2018
MULTILINK AUTOMIX
FDA Adverse Event
Other
·IVOCLAR VIVADENT, AG·Product code EMA·February 15, 2011
MULTILINK AUTOMIX
FDA Adverse Event
Other
·IVOCLAR VIVADENT AG·Product code EMA·March 21, 2011
MULTILINK AUTOMIX
FDA Adverse Event
Other
·IVOCLAR VIVADENT AG·Product code EMA·March 25, 2011