Medical Device Manufacturer · US , Amherst , NY

Ivoclar Vivadent, Inc.

65 submissions · 65 cleared · Since 2001
65
Total
65
Cleared
0
Denied

Ivoclar Vivadent, Inc. — FDA 510(k) Submissions

Ivoclar Vivadent, Inc. has submitted 65 FDA 510(k) premarket notifications since 2001, of which 65 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Material, Tooth Shade, Resin, Agent, Tooth Bonding, Resin, Alloy, Gold-based Noble Metal, Activator, Ultraviolet, For Polymerization, Crown And Bridge, Temporary, Resin . Use the specialty filter in the sidebar to narrow results.

65 devices
1–25 of 65
IPS e.max Zirconia
K253953 · EIH Powder, Porcelain · Dental
Mar 2026 90d
Adhese 2
K252450 · KLE Agent, Tooth Bonding, Resin · Dental
Mar 2026 213d
Ivotion Base Print
K233995 · EBI Resin, Denture, Relining,... · Dental
Feb 2024 67d
TelioCAD Multi
K153753 · EBG Crown And Bridge,... · Dental
Apr 2016 105d
Accu-Dent XD Tray, Accu-Dent XD Syringe
K143575 · ELW Material, Impression · Dental
Apr 2015 107d
SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S
K132984 · ELM Denture, Plastic, Teeth · Dental
Jan 2014 112d
TETRIC EVOCERAM BULK FILL
K111958 · EBF Material, Tooth Shade, Resin · Dental
Oct 2011 95d
BLUEPHASE STYLE
K110756 · EBZ Activator, Ultraviolet,... · Dental
Aug 2011 164d
IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)
K103556 · EIH Powder, Porcelain · Dental
Apr 2011 132d
IPS EMPRESS DIRECT FLOW
K103528 · EBF Material, Tooth Shade, Resin · Dental
Feb 2011 87d
IVOBASE HYBRID, IVOBASE HIGH IMPACT
K103391 · EBI Resin, Denture, Relining,... · Dental
Feb 2011 90d
TELIO CS INLAY & TELIO CS ONLAY
K103379 · EBG Crown And Bridge,... · Dental
Feb 2011 89d
TELIO CAD
K093708 · EBG Crown And Bridge,... · Dental
Mar 2010 98d
EXCITE F AND EXCITE DSC
K093744 · KLE Agent, Tooth Bonding, Resin · Dental
Mar 2010 96d
SR PHONARES NHC
K093331 · ELM Denture, Plastic, Teeth · Dental
Jan 2010 94d
ADHESE ONE F
K090941 · KLE Agent, Tooth Bonding, Resin · Dental
Jul 2009 105d
MULTILINK IMPLANT
K090704 · EBF Material, Tooth Shade, Resin · Dental
Jun 2009 92d
BLUEPHASE 20I
K091020 · EBZ Activator, Ultraviolet,... · Dental
Jun 2009 64d
SPEEDCEM
K091019 · EMA Cement, Dental · Dental
Jun 2009 56d
MONOBOND PLUS
K090826 · KLE Agent, Tooth Bonding, Resin · Dental
May 2009 46d
EMPRESS DIRECT
K090701 · EBF Material, Tooth Shade, Resin · Dental
Apr 2009 43d
CERVITEC PLUS
K072338 · LBH Varnish, Cavity · Dental
Sep 2007 32d
IPS INLINE POM SYSTEM
K071848 · EIH Powder, Porcelain · Dental
Aug 2007 56d
ADHESE ONE
K070646 · KLE Agent, Tooth Bonding, Resin · Dental
May 2007 64d
GENESIS DIODE LASER
K062258 · GEX Powered Laser Surgical... · General & Plastic Surgery
Mar 2007 229d
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