Ivoclar Vivadent, AG
Ivoclar Vivadent, AG holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2022, with 10 FDA device recalls on record.
Top product codes for Ivoclar Vivadent, AG
FDA recalls by Ivoclar Vivadent, AG
- Z-1706-2024 — 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
- Z-1704-2024 — 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
- Z-1707-2024 — 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
- Z-1708-2024 — 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
- Z-1703-2024 — 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
- Z-1705-2024 — 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
- Z-1840-2020 — 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 technology Product Number: 686282EN
- Z-1838-2020 — 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 Product Number: 686194
- Z-1839-2020 — 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 Product Number: 686195
- Z-1837-2020 — 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 Product Number: 686193
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Ivoclar Vivadent, AG
- K210804 — Adhese Universal DC, Cention Primer
- K211916 — IPS e.max One
- K193193 — Telio CAD Abutment Solutions- extra systems
- K191453 — Cervitec F
- K191448 — Barrier Sleeves
- K191382 — IPS e.max CAD Abutment Solutions- extra systems
- K190339 — Helioseal F Plus
- K190272 — Bluephase PowerCure
- K183380 — Tetric PowerFill
- K173573 — Tetric CAD
- K163613 — Bluephase Style 20i
- K160798 — IPS e.max® Press Abutment Solutions for Viteo Base Ti
- K152103 — IPS Style Ceram, IPS Style Ceram One, IPS Style Press
- K151894 — IPS Ivocolor
- K151564 — Telio CAD Abutment Solutions
- K150393 — TETRIC EVOFLOW BULK FILL
- K150164 — Monobond Etch & Prime
- K142389 — Variolink Esthetic
- K131487 — FLUOR PROTECTOR S
- K133318 — ADHESE UNIVERSAL
- K132209 — IPS E.MAX CAD ABUTMENT SOLUTIONS
- K130436 — MULTILINK HYBRID ABUTMENT CEMENT
- K123397 — MULTILINK AUTOMIX
- K123304 — SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO
- K120053 — IPS E.MAX PRESS - ABUTMENT SOLUTIONS
- K121230 — IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE
- K121359 — IPS 99 ONE AND IPS 99 CERAM
- K120134 — IPS E.MAX PRESS MULTI
- K120432 — TELIO CS CEM IMPLANT
- K120736 — SR PHONARES II
- K033773 — CONCEPT HP ADD-ON; CONCEPT HP ENAMEL
Data sourced from openFDA. This site is unofficial and independent of the FDA.