Medical Device Manufacturer · US , Amherst , NY

Ivoclar Vivadent, Inc. - FDA 510(k) Cleared Devices

66 submissions · 66 cleared · Since 2001

Recent clearances: Tetric plus Fill, IPS e.max Zirconia, Adhese 2

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66

Total

66

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ivoclar Vivadent, Inc. Dental ✕

64 devices

1-12 of 64

Cleared Jul 01, 2026

Tetric plus Fill

Cleared Mar 10, 2026

IPS e.max Zirconia

Cleared Mar 05, 2026

Cleared Feb 23, 2024

Ivotion Base Print

Cleared Apr 12, 2016

Cleared Apr 03, 2015

Accu-Dent XD Tray, Accu-Dent XD Syringe

Cleared Jan 14, 2014

SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S

Cleared Oct 14, 2011

TETRIC EVOCERAM BULK FILL

Cleared Aug 29, 2011

BLUEPHASE STYLE

Cleared Apr 13, 2011

IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT...

Cleared Feb 25, 2011

IPS EMPRESS DIRECT FLOW

Cleared Feb 17, 2011

IVOBASE HYBRID, IVOBASE HIGH IMPACT

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