# Ivoclar Vivadent, Inc.

- Location (FDA's records): Amherst, NY
- FDA decisions: 97 (2001–2026): 97 510(k) clearances
- Names in FDA's records: Ivoclar Vivadent, Inc. (66); Ivoclar Vivadent, AG (31)
- Product codes: EBF (17), KLE (10), EIH (9), EBZ (8), EMA (7), EJT (7), NHA (6), EBG (6), ELM (5), EJS (4), LBH (4), EJH (3)
- 510(k) review time since 2016: median 130 days, against 153 for FDA's reviews in the same codes and years (8 of 17 faster)
- Predicates its devices cite: 45 (24 its own); citations of its devices by later devices: 125 (24 its own)
- Recalls linked to its devices: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ivoclar North America, Inc.: 3 (https://510kreport.com/company/ivoclar-north-america)
- Sirona Dental Systems GmbH: 2 (https://510kreport.com/company/sirona-dental-systems)
- Dentsply International, Inc.: 2 (https://510kreport.com/company/dentsply-international)
- Zhermack S.P.A.: 2 (https://510kreport.com/company/zhermack)
- Biolase Technology, Inc.: 1 (https://510kreport.com/company/biolase-technology)
- CAO Group, Inc.: 1 (https://510kreport.com/company/cao-group)
- Opusdent, Ltd.: 1 (https://510kreport.com/company/opusdent)
- Premier Laser Systems, Inc.: 1 (https://510kreport.com/company/premier-laser-systems)

## Firms that cite its devices most
- GC America, Inc.: 5 (https://510kreport.com/company/gc-america)
- CAO Group, Inc.: 4 (https://510kreport.com/company/cao-group)
- Den-Mat Holdings, LLC: 4 (https://510kreport.com/company/den-mat-holdings)
- Rizhao Huge Biomaterials Company, Ltd.: 4 (https://510kreport.com/company/rizhao-huge-biomaterials)
- Wieland Dental + Technik GmbH & Co. KG: 3 (https://510kreport.com/company/wieland-dental-technik)
- Prismatik Dentalcraft, Inc.: 3 (https://510kreport.com/company/prismatik-dentalcraft)
- Dentsply Sirona: 3 (https://510kreport.com/company/dentsply-sirona)
- Dentscare Ltda: 3 (https://510kreport.com/company/dentscare)

## Its most-cited devices
- K051705: Ips E.Max Cad/Ips E.Max Zircad (2005), cited by 21
- K042819: Tetric Evoceram (2004), cited by 14
- K062258: Genesis Diode Laser (2007), cited by 10
- K050453: Odyssey 2.4G, Denlaser Elite, Model 002-00050 (2005), cited by 9
- K093708: Telio Cad (2010), cited by 5
- K120134: Ips E.Max Press Multi (2012), cited by 5

## Recent decisions
- K261485: Tetric plus Fill;Tetric plus Flow (Jul 1, 2026)
- K253953: IPS e.max Zirconia (Mar 10, 2026)
- K252450: Adhese 2 (Mar 5, 2026)
- K233995: Ivotion Base Print (Feb 23, 2024)
- K210804: Adhese Universal DC, Cention Primer (Jun 7, 2022)
- K211916: IPS e.max One (Aug 20, 2021)
- K193193: Telio CAD Abutment Solutions- extra systems (Nov 16, 2020)
- K191453: Cervitec F (Feb 11, 2020)

Source page: https://510kreport.com/company/ivoclar-vivadent