Company · US

Ivoclar Vivadent, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2026. Name variants (Inc, Corp, punctuation) are merged.

97510(k) clearances (3 in 12 months)

44recalls (0 in 12 months)

43recalls that name a 510(k)

Product codes

Code	Device	Records
EIH	Powder, Porcelain	41
EBF	Material, Tooth Shade, Resin	21
KLE	Agent, Tooth Bonding, Resin	10
EBZ	Activator, Ultraviolet, For Polymerization	9
EJT	Alloy, Gold-Based Noble Metal	7
EMA	Cement, Dental	7
EBG	Crown And Bridge, Temporary, Resin	6
NHA	Abutment, Implant, Dental, Endosseous	6
ELM	Denture, Plastic, Teeth	5
ELW	Material, Impression	5
EJS	Alloy, Other Noble Metal	4
LBH	Varnish, Cavity	4
EJH	Alloy, Metal, Base	3
EBC	Sealant, Pit And Fissure, And Conditioner	2
EBI	Resin, Denture, Relining, Repairing, Rebasing	2
ELR	Post, Root Canal	2
GEX	Powered Laser Surgical Instrument	2
EHJ	Disk, Abrasive	1
EJJ	Alloy, Amalgam	1
EJK	Liner, Cavity, Calcium Hydroxide	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Jul 1, 2026	K261485	Tetric plus Fill;Tetric plus Flow Ivoclar Vivadent, Inc.	EBF
Mar 10, 2026	K253953	IPS e.max Zirconia Ivoclar Vivadent, Inc.	EIH
Mar 5, 2026	K252450	Adhese 2 Ivoclar Vivadent, Inc.	KLE
Feb 23, 2024	K233995	Ivotion Base Print Ivoclar Vivadent, Inc.	EBI
Jun 7, 2022	K210804	Adhese Universal DC, Cention Primer Ivoclar Vivadent, AG, LI	KLE
Aug 20, 2021	K211916	IPS e.max One Ivoclar Vivadent, AG, LI	EIH
Nov 16, 2020	K193193	Telio CAD Abutment Solutions- extra systems Ivoclar Vivadent, AG, LI	NHA
Feb 11, 2020	K191453	Cervitec F Ivoclar Vivadent, AG, LI	LBH
Oct 8, 2019	K191448	Barrier Sleeves Ivoclar Vivadent, AG, LI	PEM
Aug 26, 2019	K191382	IPS e.max CAD Abutment Solutions- extra systems Ivoclar Vivadent, AG, LI	NHA
Jul 29, 2019	K190339	Helioseal F Plus Ivoclar Vivadent, AG, LI	EBC
Jul 3, 2019	K190272	Bluephase PowerCure Ivoclar Vivadent, AG, LI	EBZ
Mar 14, 2019	K183380	Tetric PowerFill Ivoclar Vivadent, AG, LI	EBF
Jun 7, 2018	K173573	Tetric CAD Ivoclar Vivadent, AG, LI	EBF
Apr 4, 2017	K163613	Bluephase Style 20i Ivoclar Vivadent, AG, LI	EBZ
Dec 15, 2016	K160798	IPS e.max® Press Abutment Solutions for Viteo Base Ti Ivoclar Vivadent, AG, LI	NHA
May 20, 2016	K152103	IPS Style Ceram, IPS Style Ceram One, IPS Style Press Ivoclar Vivadent, AG, LI	EIH
Apr 12, 2016	K153753	TelioCAD Multi Ivoclar Vivadent, Inc.	EBG
Oct 29, 2015	K151894	IPS Ivocolor Ivoclar Vivadent, AG, LI	EIH
Sep 21, 2015	K151564	Telio CAD Abutment Solutions Ivoclar Vivadent, AG, LI	NHA
Jun 9, 2015	K150393	TETRIC EVOFLOW BULK FILL Ivoclar Vivadent, AG, LI	EBF
Apr 3, 2015	K150164	Monobond Etch & Prime Ivoclar Vivadent, AG, LI	KLE
Apr 3, 2015	K143575	Accu-Dent XD Tray, Accu-Dent XD Syringe Ivoclar Vivadent, Inc.	ELW
Nov 25, 2014	K142389	Variolink Esthetic Ivoclar Vivadent, AG, LI	EBF
Oct 8, 2014	K131487	FLUOR PROTECTOR S Ivoclar Vivadent, AG	LBH
Feb 11, 2014	K133318	ADHESE UNIVERSAL Ivoclar Vivadent, AG	KLE
Jan 14, 2014	K132984	SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S Ivoclar Vivadent, Inc.	ELM
Oct 31, 2013	K132209	IPS E.MAX CAD ABUTMENT SOLUTIONS Ivoclar Vivadent, AG	NHA
Aug 20, 2013	K130436	MULTILINK HYBRID ABUTMENT CEMENT Ivoclar Vivadent, AG	EMA
Jan 31, 2013	K123397	MULTILINK AUTOMIX Ivoclar Vivadent, AG, LI	EBF
Jan 24, 2013	K123304	SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO Ivoclar Vivadent, AG	EBF
Oct 18, 2012	K120053	IPS E.MAX PRESS - ABUTMENT SOLUTIONS Ivoclar Vivadent, AG	NHA
Aug 29, 2012	K121230	IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE Ivoclar Vivadent, AG, LI	EBF
Jul 27, 2012	K121359	IPS 99 ONE AND IPS 99 CERAM Ivoclar Vivadent, AG	EIH
Jun 25, 2012	K120134	IPS E.MAX PRESS MULTI Ivoclar Vivadent, AG	EIH
Jun 8, 2012	K120432	TELIO CS CEM IMPLANT Ivoclar Vivadent, AG	EMA
May 14, 2012	K120736	SR PHONARES II Ivoclar Vivadent, AG	ELM
Oct 14, 2011	K111958	TETRIC EVOCERAM BULK FILL Ivoclar Vivadent, Inc.	EBF
Aug 29, 2011	K110756	BLUEPHASE STYLE Ivoclar Vivadent, Inc.	EBZ
Apr 13, 2011	K103556	IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE) Ivoclar Vivadent, Inc.	EIH
Feb 25, 2011	K103528	IPS EMPRESS DIRECT FLOW Ivoclar Vivadent, Inc.	EBF
Feb 17, 2011	K103391	IVOBASE HYBRID, IVOBASE HIGH IMPACT Ivoclar Vivadent, Inc.	EBI
Feb 14, 2011	K103379	TELIO CS INLAY & TELIO CS ONLAY Ivoclar Vivadent, Inc.	EBG
Mar 10, 2010	K093744	EXCITE F AND EXCITE DSC Ivoclar Vivadent, Inc.	KLE
Mar 10, 2010	K093708	TELIO CAD Ivoclar Vivadent, Inc.	EBG
Jan 28, 2010	K093331	SR PHONARES NHC Ivoclar Vivadent, Inc.	ELM
Jul 17, 2009	K090941	ADHESE ONE F Ivoclar Vivadent, Inc.	KLE
Jun 17, 2009	K090704	MULTILINK IMPLANT Ivoclar Vivadent, Inc.	EBF
Jun 12, 2009	K091020	BLUEPHASE 20I Ivoclar Vivadent, Inc.	EBZ
Jun 4, 2009	K091019	SPEEDCEM Ivoclar Vivadent, Inc.	EMA

Newest 50 of 97.

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Apr 30, 2024	IVOCLAR VIVADENT AG IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758443 Open, Classified	EIH	K051705
Apr 30, 2024	IVOCLAR VIVADENT AG IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758441 Open, Classified	EIH	K051705
Apr 30, 2024	IVOCLAR VIVADENT AG IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth Article Number: 758439 Open, Classified	EIH	K051705
Apr 30, 2024	IVOCLAR VIVADENT AG IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438 Open, Classified	EIH	K051705
Apr 30, 2024	IVOCLAR VIVADENT AG IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758437 Open, Classified	EIH	K051705
Apr 30, 2024	IVOCLAR VIVADENT AG IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758434 Open, Classified	EIH	K051705
Feb 7, 2024	Ivoclar Vivadent, Inc. Article No. NA6050411, Valiant PhD No. 1 Econo Open, Classified	EJJ	K820389
Apr 13, 2020	Ivoclar Vivadent AG Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technolog Terminated	EIH	K051705
Apr 13, 2020	Ivoclar Vivadent AG Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Terminated	EIH	K051705
Apr 13, 2020	Ivoclar Vivadent AG Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Terminated	EIH	K051705
Apr 13, 2020	Ivoclar Vivadent AG Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/CAM technology Pr Terminated	EIH	K051705
Aug 3, 2017	Ivoclar Vivadent, Inc. Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559 Terminated	EBF	K884588
Aug 3, 2017	Ivoclar Vivadent, Inc. Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503 Terminated	EBF	K884588
Aug 3, 2017	Ivoclar Vivadent, Inc. Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502 Terminated	EBF	K884588
Aug 3, 2017	Ivoclar Vivadent, Inc. Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501 Terminated	EBF	K884588
Nov 9, 2016	Ivoclar Vivadent, Inc. Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material Terminated	ELW	K083739
Nov 9, 2016	Ivoclar Vivadent, Inc. Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression material Terminated	ELW	K083739
Nov 9, 2016	Ivoclar Vivadent, Inc. Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material Terminated	ELW	K083739
Jul 11, 2016	Ivoclar Vivadent, Inc. OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # Terminated	EHJ	None listed
May 27, 2016	Ivoclar Vivadent, Inc. Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain Terminated	EIH	K152118
May 27, 2016	Ivoclar Vivadent, Inc. Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain Terminated	EIH	K152118
May 27, 2016	Ivoclar Vivadent, Inc. Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain Terminated	EIH	K152118
May 27, 2016	Ivoclar Vivadent, Inc. Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain Terminated	EIH	K152118
May 27, 2016	Ivoclar Vivadent, Inc. Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental porcelain Terminated	EIH	K152118
May 27, 2016	Ivoclar Vivadent, Inc. Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring dental porcelain Terminated	EIH	K152118
May 27, 2016	Ivoclar Vivadent, Inc. Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain Terminated	EIH	K152118
May 27, 2016	Ivoclar Vivadent, Inc. Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring dental porcelain Terminated	EIH	K152118
May 27, 2016	Ivoclar Vivadent, Inc. Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring dental porcelain Terminated	EIH	K152118
May 27, 2016	Ivoclar Vivadent, Inc. Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain Terminated	EIH	K152118
May 27, 2016	Ivoclar Vivadent, Inc. Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring dental porcelain Terminated	EIH	K152118
May 27, 2016	Ivoclar Vivadent, Inc. Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain Terminated	EIH	K152118
May 27, 2016	Ivoclar Vivadent, Inc. Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain Terminated	EIH	K152118
May 27, 2016	Ivoclar Vivadent, Inc. Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain Terminated	EIH	K152118
May 27, 2016	Ivoclar Vivadent, Inc. Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring dental porcelain Terminated	EIH	K152118
May 27, 2016	Ivoclar Vivadent, Inc. Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain Terminated	EIH	K152118
May 27, 2016	Ivoclar Vivadent, Inc. Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain Terminated	EIH	K152118
May 27, 2016	Ivoclar Vivadent, Inc. Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain Terminated	EIH	K152118
May 27, 2016	Ivoclar Vivadent, Inc. Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain Terminated	EIH	K152118
May 27, 2016	Ivoclar Vivadent, Inc. Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain Terminated	EIH	K152118
May 27, 2016	Ivoclar Vivadent, Inc. Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain Terminated	EIH	K152118
Feb 29, 2016	Ivoclar Vivadent, Inc. Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant Terminated	EBC	K813015
Jul 27, 2015	Ivoclar Vivadent, Inc. IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabrication of dental restorations Terminated	EIH	K012174
Jun 9, 2014	Ivoclar Vivadent, Inc. bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an accessory to a dental curing light Ultraviolet activator for polymerization for use du Terminated	EBZ	K110756
Nov 21, 2013	Ivoclar Vivadent, Inc. ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations Terminated	MZW	K093744

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