Ivoclar Vivadent, Inc.

FDA Regulatory Profile

Summary

Total Recalls
44
510(k) Clearances
96
Inspections
7
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1703-2024Class IIIPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, fulApril 5, 2024
Z-1708-2024Class IIIPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, fullApril 5, 2024
Z-1705-2024Class IIIPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, fullApril 5, 2024
Z-1706-2024Class IIIPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, fullApril 5, 2024
Z-1704-2024Class IIIPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of fixed, fulApril 5, 2024
Z-1707-2024Class IIIPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, fullApril 5, 2024
Z-1006-2024Class IIArticle No. NA6050411, Valiant PhD No. 1 EconoDecember 21, 2023
Z-1837-2020Class IIIvoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental use, intended for IPS e.April 13, 2020
Z-1840-2020Class IIIvoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS April 13, 2020
Z-1839-2020Class IIIvoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS eApril 13, 2020
Z-1838-2020Class IIIvoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS eApril 13, 2020
Z-0665-2018Class IIIHeliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501August 3, 2017
Z-0668-2018Class IIIHeliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559August 3, 2017
Z-0666-2018Class IIIHeliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502August 3, 2017
Z-0667-2018Class IIIHeliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503August 3, 2017
Z-0717-2017Class IIVirtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- November 9, 2016
Z-0718-2017Class IIVirtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY November 9, 2016
Z-0719-2017Class IIVirtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- ProdNovember 9, 2016
Z-2373-2016Class IIOptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill SJuly 11, 2016
Z-0021-2017Class IIZenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelainMay 27, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K253953IPS e.max ZirconiaMarch 10, 2026
K252450Adhese 2March 5, 2026
K233995Ivotion Base PrintFebruary 23, 2024
K210804Adhese Universal DC, Cention PrimerJune 7, 2022
K211916IPS e.max OneAugust 20, 2021
K193193Telio CAD Abutment Solutions- extra systemsNovember 16, 2020
K191453Cervitec FFebruary 11, 2020
K191448Barrier SleevesOctober 8, 2019
K191382IPS e.max CAD Abutment Solutions- extra systemsAugust 26, 2019
K190339Helioseal F PlusJuly 29, 2019
K190272Bluephase PowerCureJuly 3, 2019
K183380Tetric PowerFillMarch 14, 2019
K173573Tetric CADJune 7, 2018
K163613Bluephase Style 20iApril 4, 2017
K160798IPS e.max® Press Abutment Solutions for Viteo Base TiDecember 15, 2016
K152103IPS Style Ceram, IPS Style Ceram One, IPS Style PressMay 20, 2016
K153753TelioCAD MultiApril 12, 2016
K151894IPS IvocolorOctober 29, 2015
K151564Telio CAD Abutment SolutionsSeptember 21, 2015
K150393TETRIC EVOFLOW BULK FILLJune 9, 2015