# Kuraray Co.

- Location (FDA's records): New York, NY
- FDA decisions: 35 (1985–2000): 35 510(k) clearances
- Names in FDA's records: Kuraray Co. (25); Kuraray Company, Ltd. (10)
- Product codes: EBF (18), KLE (10), EMA (4), EBC (2), LFC (1)
- Predicates its devices cite: 8 (3 its own); citations of its devices by later devices: 43 (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
- Kuraray America, Inc.: 1 (https://510kreport.com/company/kuraray-america)
- Dentsply Intl.: 1 (https://510kreport.com/company/dentsply-intl)
- Heraeus Kulzer, Inc.: 1 (https://510kreport.com/company/heraeus-kulzer)
- Bisco, Inc.: 1 (https://510kreport.com/company/bisco)
- Kerr Corporation (Danbury): 1 (https://510kreport.com/company/kerr-danbury)

## Firms that cite its devices most
- Kuraray Medical, Inc.: 16 (https://510kreport.com/company/kuraray-medical)
- Kuraray America, Inc.: 7 (https://510kreport.com/company/kuraray-america)
- Tokuyama America, Inc.: 4 (https://510kreport.com/company/tokuyama-america)
- Bisco, Inc.: 2 (https://510kreport.com/company/bisco)
- Pulpdent Corp.: 1 (https://510kreport.com/company/pulpdent)
- Schutz-Dental GmbH: 1 (https://510kreport.com/company/schutz-dental)
- Ultradent Products, Inc.: 1 (https://510kreport.com/company/ultradent-products)
- Voco GmbH: 1 (https://510kreport.com/company/voco)

## Its most-cited devices
- K943165: Clearfil Photo Bond (1994), cited by 6
- K933030: Panavia 21 (1994), cited by 6
- K990040: Clearfil SE Bond (1999), cited by 5
- K943168: Clearfil AP-X (1994), cited by 3
- K882006: Clearfil Photo Core (1988), cited by 3
- K943170: Clearfil Liner Bond 2 (1994), cited by 3

## Recent decisions
- K001914: Clearfil Repair (Aug 10, 2000)
- K001913: Clearfil ST Opaquer (Aug 4, 2000)
- K990040: Clearfil SE Bond (Feb 4, 1999)
- K980232: Clearfil DC Cement (Feb 24, 1998)
- K965091: Teethmate F-1 (Mar 27, 1997)
- K951813: Caries Detector (Jul 11, 1995)
- K943168: Clearfil AP-X (Aug 10, 1994)
- K943169: Clearfil AP-X and Liner Bond 2 (Aug 10, 1994)

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