Medical Device Manufacturer · US , Amherst , NY

Ivoclar Vivadent, AG

31 submissions · 31 cleared · Since 2004
31
Total
31
Cleared
0
Denied

Ivoclar Vivadent, AG — FDA 510(k) Submissions

Ivoclar Vivadent, AG has submitted 31 FDA 510(k) premarket notifications since 2004, of which 31 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Material, Tooth Shade, Resin, Abutment, Implant, Dental, Endosseous, Powder, Porcelain, Agent, Tooth Bonding, Resin, Cement, Dental . Use the specialty filter in the sidebar to narrow results.

31 devices
1–25 of 31
Adhese Universal DC, Cention Primer
K210804 · KLE Agent, Tooth Bonding, Resin · Dental
Jun 2022 447d
IPS e.max One
K211916 · EIH Powder, Porcelain · Dental
Aug 2021 60d
Telio CAD Abutment Solutions- extra systems
K193193 · NHA Abutment, Implant,... · Dental
Nov 2020 363d
Cervitec F
K191453 · LBH Varnish, Cavity · Dental
Feb 2020 256d
Barrier Sleeves
K191448 · PEM Dental Barriers And Sleeves · Dental
Oct 2019 130d
IPS e.max CAD Abutment Solutions- extra systems
K191382 · NHA Abutment, Implant,... · Dental
Aug 2019 95d
Helioseal F Plus
K190339 · EBC Sealant, Pit And Fissure,... · Dental
Jul 2019 165d
Bluephase PowerCure
K190272 · EBZ Activator, Ultraviolet,... · Dental
Jul 2019 145d
Tetric PowerFill
K183380 · EBF Material, Tooth Shade, Resin · Dental
Mar 2019 98d
Tetric CAD
K173573 · EBF Material, Tooth Shade, Resin · Dental
Jun 2018 199d
Bluephase Style 20i
K163613 · EBZ Activator, Ultraviolet,... · Dental
Apr 2017 103d
IPS e.max? Press Abutment Solutions for Viteo Base Ti
K160798 · NHA Abutment, Implant,... · Dental
Dec 2016 267d
IPS Style Ceram, IPS Style Ceram One, IPS Style Press
K152103 · EIH Powder, Porcelain · Dental
May 2016 296d
IPS Ivocolor
K151894 · EIH Powder, Porcelain · Dental
Oct 2015 111d
Telio CAD Abutment Solutions
K151564 · NHA Abutment, Implant,... · Dental
Sep 2015 103d
TETRIC EVOFLOW BULK FILL
K150393 · EBF Material, Tooth Shade, Resin · Dental
Jun 2015 111d
Monobond Etch & Prime
K150164 · KLE Agent, Tooth Bonding, Resin · Dental
Apr 2015 67d
Variolink Esthetic
K142389 · EBF Material, Tooth Shade, Resin · Dental
Nov 2014 90d
FLUOR PROTECTOR S
K131487 · LBH Varnish, Cavity · Dental
Oct 2014 503d
ADHESE UNIVERSAL
K133318 · KLE Agent, Tooth Bonding, Resin · Dental
Feb 2014 106d
IPS E.MAX CAD ABUTMENT SOLUTIONS
K132209 · NHA Abutment, Implant,... · Dental
Oct 2013 107d
MULTILINK HYBRID ABUTMENT CEMENT
K130436 · EMA Cement, Dental · Dental
Aug 2013 180d
MULTILINK AUTOMIX
K123397 · EBF Material, Tooth Shade, Resin · Dental
Jan 2013 87d
SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO
K123304 · EBF Material, Tooth Shade, Resin · Dental
Jan 2013 92d
IPS E.MAX PRESS - ABUTMENT SOLUTIONS
K120053 · NHA Abutment, Implant,... · Dental
Oct 2012 286d
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