# Kuraray Medical Kurashiki Plant

- Location (FDA's records): New York, NY
- FDA decisions: 2 (2004–2005): 2 510(k) clearances
- Product codes: EBF (1), KLE (1)
- Predicates its devices cite: 12 (0 its own); citations of its devices by later devices: 4 (0 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
- Kuraray Medical, Inc.: 5 (https://510kreport.com/company/kuraray-medical)
- Heraeus Kulzer, Inc.: 2 (https://510kreport.com/company/heraeus-kulzer)
- Espe Dental AG: 1 (https://510kreport.com/company/espe-dental)
- Ivoclar North America, Inc.: 1 (https://510kreport.com/company/ivoclar-north-america)
- Shofu Dental Corp.: 1 (https://510kreport.com/company/shofu-dental)
- Jeneric/Pentron, Inc.: 1 (https://510kreport.com/company/jeneric-pentron)
- Sybron Dental Specialties, Inc.: 1 (https://510kreport.com/company/sybron-dental-specialties)

## Firms that cite its devices most
- Kuraray America, Inc.: 2 (https://510kreport.com/company/kuraray-america)
- Voco GmbH: 1 (https://510kreport.com/company/voco)
- Kuraray Noritake Dental, Inc.: 1 (https://510kreport.com/company/kuraray-noritake-dental)

## Its most-cited devices
- K042929: Estenia C&B (2004), cited by 3
- K051796: Clearfil Tri-S Bond Single Dose (2005), cited by 1

## Recent decisions
- K051796: Clearfil Tri-S Bond Single Dose (Aug 9, 2005)
- K042929: Estenia C&B (Dec 6, 2004)

Source page: https://510kreport.com/company/kuraray-medical-kurashiki-plant