Data / Medical devices / Liechtenstein / Ivoclar Vivadent AG
Ivoclar Vivadent AG: FDA-registered device maker in Schaan, Liechtenstein, 74 510(k) clearances
Ivoclar Vivadent AG is registered with the FDA (registration 9612352) in Schaan, Liechtenstein. It lists 32 device types. The FDA files 74 510(k) clearances under its listings, the newest dated July 1, 2026. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9612352
- FEI number
- 3002808636
- Address
- Bendererstrasse 2, Schaan, Liechtenstein, FL-9494
- Owner or operator
- IVOCLAR VIVADENT (8010208)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- February 10, 1982
- Registered through
- 2027
- Brand names listed
- Abutment Solutions for CEREC/InLab Starter Kit, AccuDent XD Impression Tray, AccuDent XD Tray Adhesive, Adhese 100, Adhese 2, Adhese 2 100, Adhese Universal, Adhese Universal DC and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 1, 2026 | K261485 | Tetric plus Fill;Tetric plus Flow | EBF | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| March 10, 2026 | K253953 | IPS e.max Zirconia | EIH | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| March 5, 2026 | K252450 | Adhese 2 | KLE | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| February 23, 2024 | K233995 | Ivotion Base Print | EBI | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| June 7, 2022 | K210804 | Adhese Universal DC, Cention Primer | KLE | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| April 29, 2022 | K213482 | TIA Tip, Cariosity, Transillumination Accessory Tip | NTK | Substantially Equivalent | D4D Technologies, LLC | accessdata.fda.gov |
| August 20, 2021 | K211916 | IPS e.max One | EIH | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| November 16, 2020 | K193193 | Telio CAD Abutment Solutions- extra systems | NHA | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| February 11, 2020 | K191453 | Cervitec F | LBH | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| October 8, 2019 | K191448 | Barrier Sleeves | PEM | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| August 26, 2019 | K191382 | IPS e.max CAD Abutment Solutions- extra systems | NHA | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| July 29, 2019 | K190339 | Helioseal F Plus | EBC | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| July 3, 2019 | K190272 | Bluephase PowerCure | EBZ | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| March 14, 2019 | K183380 | Tetric PowerFill | EBF | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| June 7, 2018 | K173573 | Tetric CAD | EBF | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| May 20, 2016 | K152103 | IPS Style Ceram, IPS Style Ceram One, IPS Style Press | EIH | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| December 16, 2015 | K152118 | Zenostar MT, Zenostar Color Liquids | EIH | Substantially Equivalent | Wieland Dental + Technik GmbH & Co. KG | accessdata.fda.gov |
| October 29, 2015 | K151894 | IPS Ivocolor | EIH | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| September 21, 2015 | K151564 | Telio CAD Abutment Solutions | NHA | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| August 13, 2015 | K151142 | IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID | EBI | Substantially Equivalent | Wieland Dental + Technik GmbH & Co. KG | accessdata.fda.gov |
| June 9, 2015 | K150393 | TETRIC EVOFLOW BULK FILL | EBF | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| April 3, 2015 | K150164 | Monobond Etch & Prime | KLE | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| January 5, 2015 | K142233 | zenostar MO, Zenostar T, Zenostar VisualiZr | EIH | Substantially Equivalent | Wieland Dental + Technik GmbH & Co. KG | accessdata.fda.gov |
| November 25, 2014 | K142389 | Variolink Esthetic | EBF | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| October 8, 2014 | K131487 | FLUOR PROTECTOR S | LBH | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| February 11, 2014 | K133318 | ADHESE UNIVERSAL | KLE | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| February 10, 2014 | K130991 | NEXXZR(TM)T AND NEXXZR(TM)S | EIH | Substantially Equivalent | Sagemax Bioceramics, Inc. | accessdata.fda.gov |
| January 14, 2014 | K132984 | SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S | ELM | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| October 31, 2013 | K132209 | IPS E.MAX CAD ABUTMENT SOLUTIONS | NHA | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| August 20, 2013 | K130436 | MULTILINK HYBRID ABUTMENT CEMENT | EMA | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| March 29, 2013 | K124008 | IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE | NHA | Substantially Equivalent | Ivoclar Vivadent, Agin | accessdata.fda.gov |
| January 31, 2013 | K123397 | MULTILINK AUTOMIX | EBF | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| January 24, 2013 | K123304 | SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO | EBF | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| October 18, 2012 | K120053 | IPS E.MAX PRESS - ABUTMENT SOLUTIONS | NHA | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| August 29, 2012 | K121230 | IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE | EBF | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| June 25, 2012 | K120134 | IPS E.MAX PRESS MULTI | EIH | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| May 14, 2012 | K120736 | SR PHONARES II | ELM | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| August 29, 2011 | K110756 | BLUEPHASE STYLE | EBZ | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| April 13, 2011 | K103556 | IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE) | EIH | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| February 25, 2011 | K103528 | IPS EMPRESS DIRECT FLOW | EBF | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| February 17, 2011 | K103391 | IVOBASE HYBRID, IVOBASE HIGH IMPACT | EBI | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| February 14, 2011 | K103379 | TELIO CS INLAY & TELIO CS ONLAY | EBG | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| March 10, 2010 | K093744 | EXCITE F AND EXCITE DSC | KLE | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| March 10, 2010 | K093708 | TELIO CAD | EBG | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| January 28, 2010 | K093331 | SR PHONARES NHC | ELM | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| June 4, 2009 | K091019 | SPEEDCEM | EMA | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| May 11, 2009 | K090826 | MONOBOND PLUS | KLE | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| April 29, 2009 | K090701 | EMPRESS DIRECT | EBF | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| September 21, 2007 | K072338 | CERVITEC PLUS | LBH | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| October 14, 2005 | K051705 | IPS E.MAX CAD/IPS E.MAX ZIRCAD | EIH | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| December 20, 2004 | K042846 | SYSTEMP.LINK | EMA | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| November 9, 2004 | K042819 | TETRIC EVOCERAM | EBF | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| May 19, 2004 | K040951 | SR ADORO | EBG | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| May 17, 2004 | K040795 | MULTICORE HB; MULTICORE FLOW | EBF | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| November 5, 2003 | K032470 | MULTILINK | EMA | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| August 28, 2002 | K013869 | SR IVOCRON | EBG | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| February 7, 2002 | K013929 | HELIOMOLAR HB TRANSLUCENT SHADES | EBF | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| August 27, 2001 | K012174 | ERIS LAYERING MATERIALS | EIH | Substantially Equivalent | Ivoclar North America, Inc. | accessdata.fda.gov |
| December 13, 1999 | K993783 | TETRIC FLOW | EBF | Substantially Equivalent | Ivoclar North America, Inc. | accessdata.fda.gov |
| September 8, 1998 | K982616 | IPS EMPRESS 2 | EIH | Substantially Equivalent | Ivoclar North America, Inc. | accessdata.fda.gov |
| May 11, 1998 | K980986 | PROCAD | EIH | Substantially Equivalent | Ivoclar USA, Inc. | accessdata.fda.gov |
| January 22, 1997 | K964285 | TETRIC CERAM | EBF | Substantially Equivalent | Ivoclar North America, Inc. | accessdata.fda.gov |
| August 6, 1996 | K962456 | SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH | ELM | Substantially Equivalent | Ivoclar North America, Inc. | accessdata.fda.gov |
| July 22, 1994 | K930835 | VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A | ELL | Substantially Equivalent | Ivoclar North America, Inc. | accessdata.fda.gov |
| January 31, 1992 | K915377 | SR-IVOCAP PLUS | EBI | Substantially Equivalent | Ivoclar North America, Inc. | accessdata.fda.gov |
| October 17, 1991 | K913655 | PROBASE HOT AND PROBASE COLD | EBI | Substantially Equivalent | Ivoclar North America, Inc. | accessdata.fda.gov |
| June 26, 1990 | K901913 | SYNTAC (DENTIN BONDING AGENT) | KLE | Substantially Equivalent | Ivoclar North America, Inc. | accessdata.fda.gov |
| June 26, 1990 | K901261 | PV-CERAMIC, CERAMINIQUE | EIH | Substantially Equivalent | Ivoclar North America, Inc. | accessdata.fda.gov |
| April 16, 1990 | K896130 | SR-IVOCAP | EBI | Substantially Equivalent | Ivoclar North America, Inc. | accessdata.fda.gov |
| January 10, 1990 | K896132 | ENAMEL PREP ENAMEL ETCHANT (EMAIL-PREPARATOR GS) | EBF | Substantially Equivalent | Ivoclar North America, Inc. | accessdata.fda.gov |
| January 27, 1989 | K884588 | HELIOMOLAR(R) DENTAL RESTORATIVE | EBF | Substantially Equivalent | Williams Dental Co., Inc. | accessdata.fda.gov |
| February 10, 1987 | K864707 | SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH | ELM | Substantially Equivalent | Ivoclar USA, Inc. | accessdata.fda.gov |
| December 2, 1981 | K813015 | HELIOSEAL | EBC | Substantially Equivalent | Vivadent (Usa), Inc. | accessdata.fda.gov |
| November 24, 1980 | K802681 | HELIOBOND | KLE | Substantially Equivalent | Vivadent (Usa), Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 13, 2020 | 85450 | Class II | Terminated | 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 Product Number: 686193 | Restorations crack during the sintering process. | accessdata.fda.gov |
| October 7, 2015 | 72290 | Class II | Terminated | Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed f | A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty component seem to be larger than the size defined in the formula. This results in difficulties during extrusion of the material. | accessdata.fda.gov |
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Updated July 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.