# Zhermack S.P.A.

- Location (FDA's records): Bend, OR
- FDA decisions: 19 (1996–2009): 19 510(k) clearances
- Product codes: ELW (19)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 6 (0 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Ivoclar Vivadent, Inc.: 2 (https://510kreport.com/company/ivoclar-vivadent)
- Shandong Huge Dental Material Corporation: 1 (https://510kreport.com/company/shandong-huge-dental-material)
- Kettenbach GmbH & Co. KG: 1 (https://510kreport.com/company/kettenbach)
- Hrs Co., Ltd.: 1 (https://510kreport.com/company/hrs)
- Pentron Clinical: 1 (https://510kreport.com/company/pentron-clinical)

## Its most-cited devices
- K024034: Occlufast Rock (2002), cited by 2
- K043131: Torpicalgin (2004), cited by 1
- K073005: Elite Glass (2007), cited by 1
- K981091: Neocolloid, Orthoprint (1998), cited by 1
- K070700: Freealgin (2007), cited by 1

## Recent decisions
- K083739: Hydrorise and Hydrosystem (Mar 26, 2009)
- K081084: Colorise Rigid (May 14, 2008)
- K080130: Occlufast Cad (Mar 14, 2008)
- K073005: Elite Glass (Dec 12, 2007)
- K070677: Colorise (May 11, 2007)
- K070700: Freealgin (Apr 25, 2007)
- K053619: Colorbite (Mar 1, 2006)
- K050417: Elite Implant (Jul 19, 2005)

Source page: https://510kreport.com/company/zhermack