Chrysalis Intelligence · Sponsors · Ivoclar Vivadent, AG

Ivoclar Vivadent, AG

Schaan, LI · 8 510(k) clearances · 11 recalls

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Total clearances
8
2020-02-11 → 2026-07-01
Last 12 months
3
Product codes
6
Most recent
2026-07-01
Name variants in FDA filings: Ivoclar Vivadent, AG / Ivoclar Vivadent, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
EIH Powder, Porcelain Class II Dental 2 2026-03-10
KLE Agent, Tooth Bonding, Resin Class II Dental 2 2026-03-05
EBF Material, Tooth Shade, Resin Class II Dental 1 2026-07-01
EBI — — — 1 2024-02-23
NHA Abutment, Implant, Dental, Endosseous Class II Dental 1 2020-11-16
LBH Varnish, Cavity Class II Dental 1 2020-02-11
Safety

Recalls (11)

Class I (serious)
0
Risk of injury / death
Total recalls
11
Currently ongoing
7
Most recent
2024-04-05
DateSeverityStatusRecall # ProductCodeReason
2024-04-05 Class II Ongoing Z-1708-2024 IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restoration… — Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
2024-04-05 Class II Ongoing Z-1707-2024 IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restoration… — Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
2024-04-05 Class II Ongoing Z-1706-2024 IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restoration… — Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
2024-04-05 Class II Ongoing Z-1705-2024 IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restoration… — Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
2024-04-05 Class II Ongoing Z-1704-2024 IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of fixed, full-contour restoratio… — Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
2024-04-05 Class II Ongoing Z-1703-2024 IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restoratio… — Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
2023-12-21 Class II Ongoing Z-1006-2024 Article No. NA6050411, Valiant PhD No. 1 Econo — Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working ti…
2020-04-13 Class II Terminated Z-1840-2020 Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presin… — Restorations crack during the sintering process.
2020-04-13 Class II Terminated 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 presint… — Restorations crack during the sintering process.
2020-04-13 Class II Terminated 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 presinte… — Restorations crack during the sintering process.
2020-04-13 Class II Terminated 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 presinter… — Restorations crack during the sintering process.
Filings

All 510(k) clearances (8)

Date K-number Device Code Class Specialty
2026-07-01 K261485 Tetric plus Fill;Tetric plus Flow EBF Class II Dental
2026-03-10 K253953 IPS e.max Zirconia EIH Class II Dental
2026-03-05 K252450 Adhese 2 KLE Class II Dental
2024-02-23 K233995 Ivotion Base Print EBI — —
2022-06-07 K210804 Adhese Universal DC, Cention Primer KLE Class II Dental
2021-08-20 K211916 IPS e.max One EIH Class II Dental
2020-11-16 K193193 Telio CAD Abutment Solutions- extra systems NHA Class II Dental
2020-02-11 K191453 Cervitec F LBH Class II Dental
Data source: openFDA · Generated 2026-08-27 08:58 · Last ingest 2026-08-27T12:58:10.687222 · Pipeline: Chrysalis Intelligence