FDAAugust 3, 2017device
Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.
What to do
FDA enforcement status: Terminated
Brands named
ivoclar vivadentivoclar
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAIPS 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: 7584432024-04-05
- FDAIPS 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: 7584392024-04-05
- FDAIPS 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: 7584372024-04-05
- FDAIPS 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: 7584342024-04-05
- FDAIPS 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: 7584382024-04-05
- FDAIPS 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: 7584412024-04-05
- FDAArticle No. NA6050411, Valiant PhD No. 1 Econo2023-12-21
- FDAIvoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 6861942020-04-13
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