# Kuraray Medical, Inc.

- Location (FDA's records): New York, NY
- FDA decisions: 42 (2001–2012): 42 510(k) clearances
- Product codes: EBF (18), KLE (14), EMA (8), LFC (1), EBC (1)
- Predicates its devices cite: 81 (39 its own); citations of its devices by later devices: 107 (39 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 Co.: 16 (https://510kreport.com/company/kuraray)
- Kuraray America, Inc.: 8 (https://510kreport.com/company/kuraray-america)
- Pulpdent Corp.: 2 (https://510kreport.com/company/pulpdent)
- 3M Espe AG Dental Products: 2 (https://510kreport.com/company/3m-espe-ag-dental-products)
- Dentsply Intl.: 2 (https://510kreport.com/company/dentsply-intl)
- Ultradent Products, Inc.: 2 (https://510kreport.com/company/ultradent-products)
- GC America, Inc.: 1 (https://510kreport.com/company/gc-america)
- Ivoclar Vivadent, Inc.: 1 (https://510kreport.com/company/ivoclar-vivadent)

## Firms that cite its devices most
- Kuraray Noritake Dental, Inc.: 23 (https://510kreport.com/company/kuraray-noritake-dental)
- Kuraray America, Inc.: 16 (https://510kreport.com/company/kuraray-america)
- Kuraray Medical Kurashiki Plant: 5 (https://510kreport.com/company/kuraray-medical-kurashiki-plant)
- Vericom Co., Ltd.: 3 (https://510kreport.com/company/vericom)
- 3M Espe AG Dental Products: 3 (https://510kreport.com/company/3m-espe-ag-dental-products)
- Meta Biomed Co., Ltd.: 3 (https://510kreport.com/company/meta-biomed)
- 3M Espe Dental Products: 2 (https://510kreport.com/company/3m-espe-dental-products)
- Nobio, Ltd.: 2 (https://510kreport.com/company/nobio)

## Its most-cited devices
- K032455: Panavia F 2.0 (2003), cited by 14
- K012740: Clearfil AP-X (2001), cited by 11
- K042913: Clearfil Tri-S Bond (2004), cited by 11
- K012442: Modification to Clearfil SE Bond (2001), cited by 10
- K012432: Modification to Clearfil Photo Bond (2001), cited by 5
- K061860: Clearfil Majesty Esthetic (2006), cited by 4

## Recent decisions
- K120378: Panavia SA Cement Handmix Value Pack (Universal (A2), White) Panavia SA Cement Handmix (Universal (A2), White) Panavia S (Mar 30, 2012)
- K120379: Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix (Universal (A2), White) Panavia S (Mar 30, 2012)
- K111975: Clearfil Tri-S Bond Plus Single Dose Standard / Value / Introductory Pack (Oct 14, 2011)
- K100328: Clearfil Majety Posterior (Mar 5, 2010)
- K092281: Clearfil Majesty Posterior PLT (Oct 27, 2009)
- K081583: Clearfil SA Cement (Jul 28, 2008)
- K071169: Clearfil Majesty Posterior PLT (Jun 20, 2007)
- K070325: Clearfil Majesty Esthetic PLT (Mar 21, 2007)

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