510(k) K051705 ยท EIH Powder, Porcelain
IPS E.MAX CAD/IPS E.MAX ZIRCAD
| Applicant | Ivoclar Vivadent, Inc., Amherst NY, US |
| Decision | Substantially Equivalent, Oct 14, 2005 |
| Received | Jun 24, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051705
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2024 | IVOCLAR VIVADENT AG 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 Open, Classified |
EIH | None listed |
| Apr 30, 2024 | IVOCLAR VIVADENT AG 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 Open, Classified |
EIH | None listed |
| Apr 30, 2024 | IVOCLAR VIVADENT AG 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 Open, Classified |
EIH | None listed |
| Apr 30, 2024 | IVOCLAR VIVADENT AG 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 Open, Classified |
EIH | None listed |
| Apr 30, 2024 | IVOCLAR VIVADENT AG 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 Open, Classified |
EIH | None listed |
| Apr 30, 2024 | IVOCLAR VIVADENT AG 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 Open, Classified |
EIH | None listed |
| Apr 13, 2020 | Ivoclar Vivadent AG Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/CAM technology
Pr Terminated |
EIH | None listed |
| Apr 13, 2020 | Ivoclar Vivadent AG Ivoclar 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
Terminated |
EIH | None listed |
| Apr 13, 2020 | Ivoclar Vivadent AG Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/
CAM technology Terminated |
EIH | None listed |
| Apr 13, 2020 | Ivoclar Vivadent AG Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/
CAM technolog Terminated |
EIH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.