# Kuraray America, Inc.

- Location (FDA's records): New York, NY
- FDA decisions: 11 (1997–2011): 11 510(k) clearances
- Product codes: EBF (5), KLE (3), EMA (2), EBD (1)
- Predicates its devices cite: 53 (2 its own); citations of its devices by later devices: 20 (2 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.: 16 (https://510kreport.com/company/kuraray-medical)
- Kuraray Co.: 7 (https://510kreport.com/company/kuraray)
- Ivoclar North America, Inc.: 5 (https://510kreport.com/company/ivoclar-north-america)
- Heraeus Kulzer, Inc.: 5 (https://510kreport.com/company/heraeus-kulzer)
- Bisco, Inc.: 3 (https://510kreport.com/company/bisco)
- Jeneric/Pentron, Inc.: 3 (https://510kreport.com/company/jeneric-pentron)
- Parkell, Inc.: 3 (https://510kreport.com/company/parkell)
- Kuraray Medical Kurashiki Plant: 2 (https://510kreport.com/company/kuraray-medical-kurashiki-plant)

## Firms that cite its devices most
- Kuraray Medical, Inc.: 8 (https://510kreport.com/company/kuraray-medical)
- Kuraray Noritake Dental, Inc.: 6 (https://510kreport.com/company/kuraray-noritake-dental)
- Schutz-Dental GmbH: 1 (https://510kreport.com/company/schutz-dental)
- Vita Zahnfabrik H.Rauter GmbH & Co.: 1 (https://510kreport.com/company/vita-zahnfabrik-h-rauter)
- Kuraray Co.: 1 (https://510kreport.com/company/kuraray)
- Den-Mat Holdings, LLC: 1 (https://510kreport.com/company/den-mat-holdings)

## Its most-cited devices
- K063593: Clearfil Majesty Flow (2007), cited by 5
- K063595: Clearfil Majesty Posterior (2007), cited by 3
- K974089: Alloy Primer (1997), cited by 3
- K974486: Clearfil Liner Bond  2V (1998), cited by 2
- K111980: Clearfil Tri-S Bond Plus (2011), cited by 2
- K111982: Clearfil DC Core Plus (2011), cited by 2

## Recent decisions
- K111982: Clearfil DC Core Plus (Nov 17, 2011)
- K111980: Clearfil Tri-S Bond Plus (Oct 14, 2011)
- K063595: Clearfil Majesty Posterior (Feb 9, 2007)
- K063593: Clearfil Majesty Flow (Feb 2, 2007)
- K063228: Surface Coat (Dec 8, 2006)
- K002322: Modification to Panavia F (Sep 18, 2000)
- K983361: Panavia F (Nov 13, 1998)
- K982259: Chroma Zone Color Stain (Sep 22, 1998)

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