# Cavex Holland BV

- Location (FDA's records): Haarlem, NL
- FDA decisions: 26 (1998–2015): 26 510(k) clearances
- Product codes: ELW (16), EBF (6), KLE (2), EMA (1), EMB (1)
- Predicates its devices cite: 8 (8 its own); citations of its devices by later devices: 9 (8 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Hygedent, Inc.: 1 (https://510kreport.com/company/hygedent)

## Its most-cited devices
- K051207: Cavex Orthotrace (2005), cited by 2
- K011419: Cavex Colorchange (2001), cited by 2
- K023466: Tulip Alginate Impression Material (2002), cited by 2
- K032116: Tulip Colorswitch (2003), cited by 1
- K981970: Algetral, Cavex Chromatic, CA 37 Superior Pink, CA 37 Fast Set, Cavex Rainbow, Cavex Impressional Normal Setting, Cavexi (1998), cited by 1
- K013336: Xantalgin Crono (2001), cited by 1

## Recent decisions
- K151535: Cavex Cream Alginate (Oct 28, 2015)
- K141092: MARK3 (Dec 4, 2014)
- K073539: Provisa Cem (Jan 31, 2008)
- K072245: Emulate Advanced (Nov 8, 2007)
- K062400: Impressix, Colorchange Alginate (Nov 16, 2006)
- K061267: Simulate, Color Change Alginate (Jul 10, 2006)
- K052455: Impressix (Nov 23, 2005)
- K051207: Cavex Orthotrace (Jun 21, 2005)

Source page: https://510kreport.com/company/cavex-holland