Ivoclar Vivadent, Inc.
Amherst, NY, US
IVOCLAR VIVADENT, INC. appears in FDA device records in Amherst, NY. FDA records list 97 510(k) clearances between and , no PMA records and 5 registered establishments. As of , FDA records show 45 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Ivoclar Vivadent, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Ivoclar A. G.enforcement report, recall
510(k) clearance history
Showing 50 of 97FDA records hold 97 510(k) clearances for Ivoclar Vivadent, Inc. between 2001 and 2026. The busiest year on record is 2002, with 14. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 2 |
| 2002 | 14 |
| 2003 | 8 |
| 2004 | 9 |
| 2005 | 3 |
| 2006 | 5 |
| 2007 | 4 |
| 2009 | 6 |
| 2010 | 3 |
| 2011 | 6 |
| 2012 | 6 |
| 2013 | 4 |
| 2014 | 4 |
| 2015 | 5 |
| 2016 | 3 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 5 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261485 | Tetric plus Fill;Tetric plus Flow | EBF | Substantially Equivalent | |
| K253953 | IPS e.max Zirconia | EIH | Substantially Equivalent | |
| K252450 | Adhese 2 | KLE | Substantially Equivalent | |
| K233995 | Ivotion Base Print | EBI | Substantially Equivalent | |
| K210804 | Adhese Universal DC, Cention Primer | KLE | Substantially Equivalent | |
| K211916 | IPS e.max One | EIH | Substantially Equivalent | |
| K193193 | Telio CAD Abutment Solutions- extra systems | NHA | Substantially Equivalent | |
| K191453 | Cervitec F | LBH | Substantially Equivalent | |
| K191448 | Barrier Sleeves | PEM | Substantially Equivalent | |
| K191382 | IPS e.max CAD Abutment Solutions- extra systems | NHA | Substantially Equivalent | |
| K190339 | Helioseal F Plus | EBC | Substantially Equivalent | |
| K190272 | Bluephase PowerCure | EBZ | Substantially Equivalent | |
| K183380 | Tetric PowerFill | EBF | Substantially Equivalent | |
| K173573 | Tetric CAD | EBF | Substantially Equivalent | |
| K163613 | Bluephase Style 20i | EBZ | Substantially Equivalent | |
| K160798 | IPS e.max® Press Abutment Solutions for Viteo Base Ti | NHA | Substantially Equivalent | |
| K152103 | IPS Style Ceram, IPS Style Ceram One, IPS Style Press | EIH | Substantially Equivalent | |
| K153753 | TelioCAD Multi | EBG | Substantially Equivalent | |
| K151894 | IPS Ivocolor | EIH | Substantially Equivalent | |
| K151564 | Telio CAD Abutment Solutions | NHA | Substantially Equivalent | |
| K150393 | TETRIC EVOFLOW BULK FILL | EBF | Substantially Equivalent | |
| K150164 | Monobond Etch & Prime | KLE | Substantially Equivalent | |
| K143575 | Accu-Dent XD Tray, Accu-Dent XD Syringe | ELW | Substantially Equivalent | |
| K142389 | Variolink Esthetic | EBF | Substantially Equivalent | |
| K131487 | FLUOR PROTECTOR S | LBH | Substantially Equivalent | |
| K133318 | ADHESE UNIVERSAL | KLE | Substantially Equivalent | |
| K132984 | SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S | ELM | Substantially Equivalent | |
| K132209 | IPS E.MAX CAD ABUTMENT SOLUTIONS | NHA | Substantially Equivalent | |
| K130436 | MULTILINK HYBRID ABUTMENT CEMENT | EMA | Substantially Equivalent | |
| K123397 | MULTILINK AUTOMIX | EBF | Substantially Equivalent | |
| K123304 | SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO | EBF | Substantially Equivalent | |
| K120053 | IPS E.MAX PRESS - ABUTMENT SOLUTIONS | NHA | Substantially Equivalent | |
| K121230 | IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE | EBF | Substantially Equivalent | |
| K121359 | IPS 99 ONE AND IPS 99 CERAM | EIH | Substantially Equivalent | |
| K120134 | IPS E.MAX PRESS MULTI | EIH | Substantially Equivalent | |
| K120432 | TELIO CS CEM IMPLANT | EMA | Substantially Equivalent | |
| K120736 | SR PHONARES II | ELM | Substantially Equivalent | |
| K111958 | TETRIC EVOCERAM BULK FILL | EBF | Substantially Equivalent | |
| K110756 | BLUEPHASE STYLE | EBZ | Substantially Equivalent | |
| K103556 | IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE) | EIH | Substantially Equivalent | |
| K103528 | IPS EMPRESS DIRECT FLOW | EBF | Substantially Equivalent | |
| K103391 | IVOBASE HYBRID, IVOBASE HIGH IMPACT | EBI | Substantially Equivalent | |
| K103379 | TELIO CS INLAY & TELIO CS ONLAY | EBG | Substantially Equivalent | |
| K093744 | EXCITE F AND EXCITE DSC | KLE | Substantially Equivalent | |
| K093708 | TELIO CAD | EBG | Substantially Equivalent | |
| K093331 | SR PHONARES NHC | ELM | Substantially Equivalent | |
| K090941 | ADHESE ONE F | KLE | Substantially Equivalent | |
| K090704 | MULTILINK IMPLANT | EBF | Substantially Equivalent | |
| K091020 | BLUEPHASE 20I | EBZ | Substantially Equivalent | |
| K091019 | SPEEDCEM | EMA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9612352 | 3002808636 | IVOCLAR VIVADENT AG | BENDERERSTRASSE 2, SCHAAN FL-9494 LI | 2026 | and 22 more, listed in full below |
| 1316092 | 1316092 | IVOCLAR VIVADENT, INC. | 175 PINEVIEW DR., AMHERST, NY 14228 US | 2026 | and 1 more, listed in full below |
| 3004362235 | 3004362235 | IVOCLAR VIVADENT, INC. | Phase 3, Block 9C, Lot 5, Lipa City Batangas 4217 PH | 2026 | |
| 3009496224 | 3009496224 | IVOCLAR VIVADENT, INC. | 1-6600 Dixie Road, Mississauga Ontario L5T 2Y CA | 2026 | and 27 more, listed in full below |
| 3004966444 | 3004966444 | Ivoclar Vivadent GmbH | Dr. Adolf-Schneider-Str.4, Ellwangen Baden-Wurttemberg D-73479 DE | 2026 | and 20 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- NDPAccessories, Implant, Dental, Endosseous
- EIFAccessories, Retractor, Dental
- EBZActivator, Ultraviolet, For Polymerization
- EJRAgent, Polishing, Abrasive, Oral Cavity
- KLEAgent, Tooth Bonding, Resin
- EJJAlloy, Amalgam
- EJTAlloy, Gold-Based Noble Metal
- EJHAlloy, Metal, Base
- EJSAlloy, Other Noble Metal
- EFDAmalgamator, Dental, Ac-Powered
- KXRApplicator, Resin
- EJPArticulators
- EMACement, Dental
- EBDCoating, Filling Material, Resin
- EBGCrown And Bridge, Temporary, Resin
- EIEDam, Rubber
- PNPDental Abutment Design Software For Dental Laboratory
- PEMDental Barriers And Sleeves
- ELMDenture, Plastic, Teeth
- EHJDisk, Abrasive
- KCRFacebow
- EILGauge, Depth, Instrument, Dental
- EEGHeat Source For Bleaching Teeth
- KZOInk, Arch Tracing
- DZNInstruments, Dental Hand
- NTKLight Transmission Caries Detector
- EJKLiner, Cavity, Calcium Hydroxide
- ELWMaterial, Impression
- EBHMaterial, Impression Tray, Resin
- EBFMaterial, Tooth Shade, Resin
- DYNMouthpiece, Saliva Ejector
- ELRPost, Root Canal
- EIHPowder, Porcelain
- GEXPowered Laser Surgical Instrument
- EBIResin, Denture, Relining, Repairing, Rebasing
- EBCSealant, Pit And Fissure, And Conditioner
- EIDSyringe, Restorative And Impression Material
- ELLTeeth, Porcelain
- EHYTray, Impression, Preformed
- LBHVarnish, Cavity
- EGDWax, Dental, Intraoral
Recall records
Showing 25 of 45| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1708-2024 | 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 | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration | Class II | Open, Classified | |
| Z-1707-2024 | 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 | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration | Class II | Open, Classified | |
| Z-1706-2024 | 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 | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration | Class II | Open, Classified | |
| Z-1705-2024 | 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 | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration | Class II | Open, Classified | |
| Z-1704-2024 | 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 | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration | Class II | Open, Classified | |
| Z-1703-2024 | 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 | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration | Class II | Open, Classified | |
| Z-1006-2024 | Article No. NA6050411, Valiant PhD No. 1 Econo | Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely affected. | Class II | Open, Classified | |
| Z-1840-2020 | 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 technology Product Number: 686282EN | Restorations crack during the sintering process. | Class II | Terminated | |
| Z-1839-2020 | 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 Product Number: 686195 | Restorations crack during the sintering process. | Class II | Terminated | |
| Z-1838-2020 | 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 Product Number: 686194 | Restorations crack during the sintering process. | Class II | Terminated | |
| Z-1837-2020 | 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. | Class II | Terminated | |
| Z-0668-2018 | Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559 | Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring. | Class III | Terminated | |
| Z-0667-2018 | Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503 | Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring. | Class III | Terminated | |
| Z-0666-2018 | Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502 | Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring. | Class III | Terminated | |
| Z-0665-2018 | Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501 | Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring. | Class III | Terminated | |
| Z-0719-2017 | Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material | The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase. | Class II | Terminated | |
| Z-0718-2017 | Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression material | The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase. | Class II | Terminated | |
| Z-0717-2017 | Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material | The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase. | Class II | Terminated | |
| Z-2373-2016 | 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 # B106952. One step polishing system for all common dental composites and amalgam. | After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away. OptraPol Small Flame is also affected. Two complaints were filed referring to OptraPol, claiming that the abrasive polishers wear faster than expected. | Class II | Terminated | |
| Z-0037-2017 | Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | Class II | Terminated | |
| Z-0036-2017 | Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | Class II | Terminated | |
| Z-0035-2017 | Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | Class II | Terminated | |
| Z-0034-2017 | Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | Class II | Terminated | |
| Z-0033-2017 | Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental porcelain | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | Class II | Terminated | |
| Z-0032-2017 | Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring dental porcelain | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain