# Vertex-Dental B.V.

- Location (FDA's records): Soesterberg, NL
- FDA decisions: 8 (2010–2024): 8 510(k) clearances
- Product codes: EBI (7), MQC (1)
- 510(k) review time since 2016: median 161 days, against 120 for FDA's reviews in the same codes and years (0 of 5 faster)
- Predicates its devices cite: 12 (3 its own); citations of its devices by later devices: 20 (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
- Ivoclar North America, Inc.: 2 (https://510kreport.com/company/ivoclar-north-america)
- Major Prodotti Dentari S.P.A.: 2 (https://510kreport.com/company/major-prodotti-dentari)
- Sprintray, Inc.: 1 (https://510kreport.com/company/sprintray)
- Dentca, Inc.: 1 (https://510kreport.com/company/dentca)
- Saremco Dental AG: 1 (https://510kreport.com/company/saremco-dental)
- Thermoplastic Comfort Systems, Inc.: 1 (https://510kreport.com/company/thermoplastic-comfort-systems)
- Dentsply Intl.: 1 (https://510kreport.com/company/dentsply-intl)

## Firms that cite its devices most
- Shandong Huge Dental Material Corporation: 2 (https://510kreport.com/company/shandong-huge-dental-material)
- Merz Dental GmbH: 2 (https://510kreport.com/company/merz-dental)
- Dentsply Sirona: 1 (https://510kreport.com/company/dentsply-sirona)
- Park Dental Research Corp.: 1 (https://510kreport.com/company/park-dental-research)
- Pro3Dure Medical GmbH: 1 (https://510kreport.com/company/pro3dure-medical)
- Hangzhou SHINING3D Dental Technology Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-shining3d-dental-technology)
- Envisiontec GmbH: 1 (https://510kreport.com/company/envisiontec)
- Yamahachi Dental Manufacturing Co.: 1 (https://510kreport.com/company/yamahachi-dental-manufacturing)

## Its most-cited devices
- K191497: NextDent Denture 3D+ (2019), cited by 6
- K162572: NextDent Denture, E-Denture (2017), cited by 5
- K102640: Vertex Self Curing, Vertex Castavaria, Vertex Castapress (2011), cited by 3
- K102654: Vertex Rapid Simplified (2010), cited by 2
- K123220: Vertex Thermosens Rigid (2013), cited by 2
- K231388: NextDent Base (2023), cited by 1

## Recent decisions
- K241071: NextDent Jet Denture Base; NextDent Jet Denture Teeth (Sep 4, 2024)
- K231388: NextDent Base (Oct 20, 2023)
- K221022: NextDent Ortho Flex (Oct 21, 2022)
- K191497: NextDent Denture 3D+ (Nov 1, 2019)
- K162572: NextDent Denture, E-Denture (Jun 30, 2017)
- K123220: Vertex Thermosens Rigid (Mar 1, 2013)
- K102640: Vertex Self Curing, Vertex Castavaria, Vertex Castapress (Mar 25, 2011)
- K102654: Vertex Rapid Simplified (Dec 3, 2010)

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