# Materialise Dental NV

- Location (FDA's records): Leuven, BE
- FDA decisions: 5 (2008–2012): 5 510(k) clearances
- Product codes: LLZ (5)
- Predicates its devices cite: 8 (3 its own); citations of its devices by later devices: 13 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Materialise NV: 2 (https://510kreport.com/company/materialise)
- Nobel Biocare AB: 2 (https://510kreport.com/company/nobel-biocare)
- Ivoclar Vivadent, Inc.: 1 (https://510kreport.com/company/ivoclar-vivadent)

## Firms that cite its devices most
- Dentsply Sirona: 4 (https://510kreport.com/company/dentsply-sirona)
- Sicat GmbH & Co. KG: 3 (https://510kreport.com/company/sicat)
- 3Shape Medical A/S: 2 (https://510kreport.com/company/3shape-medical-a-s)
- Media Lab S.R.L.: 1 (https://510kreport.com/company/media-lab)

## Its most-cited devices
- K110300: Simplant 2011 (2011), cited by 9
- K081402: Simplant Ortho ; Vistadent 3D (2008), cited by 3
- K113739: Simplant Immediate Smile Dental Care System (2012), cited by 1

## Recent decisions
- K120733: Simplant GO (Jul 5, 2012)
- K113739: Simplant Immediate Smile Dental Care System (May 30, 2012)
- K112679: Simplant Navigator Personalized Dental Care System (Feb 22, 2012)
- K110300: Simplant 2011 (Jul 1, 2011)
- K081402: Simplant Ortho ; Vistadent 3D (Jul 18, 2008)

Source page: https://510kreport.com/company/materialise-dental