# Tokuyama America, Inc.

- Location (FDA's records): Washington, DC
- FDA decisions: 22 (1990–2002): 22 510(k) clearances
- Product codes: EBF (10), EBI (5), KLE (4), EMA (3)
- Predicates its devices cite: 11 (4 its own); citations of its devices by later devices: 14 (4 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.: 4 (https://510kreport.com/company/kuraray)
- Parkell, Inc.: 3 (https://510kreport.com/company/parkell)

## Firms that cite its devices most
- Tokuyama Dental Corporation: 8 (https://510kreport.com/company/tokuyama-dental)
- Roydent Dental Products, Inc.: 1 (https://510kreport.com/company/roydent-dental-products)
- Kuraray Medical, Inc.: 1 (https://510kreport.com/company/kuraray-medical)

## Its most-cited devices
- K953589: Tokuyama Soft Relining (1996), cited by 2
- K991711: Bistite II SC (1999), cited by 2
- K982537: Tokuyama Sofreliner (1998), cited by 2
- K980051: Palfique Estelite Paste (1998), cited by 2
- K993917: Tokuyama One-UP-Bond F (2000), cited by 1
- K010267: Palfique Estelite LV Clear (2001), cited by 1

## Recent decisions
- K022641: Tokuyama Rebase II (Oct 2, 2002)
- K011854: Tokuyama M-Bond (Sep 4, 2001)
- K011685: Bistite II DC (Jul 31, 2001)
- K010267: Palfique Estelite LV Clear (Feb 27, 2001)
- K002863: Palfique Estelite LV (Jan 4, 2001)
- K993917: Tokuyama One-UP-Bond F (Feb 2, 2000)
- K991711: Bistite II SC (Jul 7, 1999)
- K982537: Tokuyama Sofreliner (Aug 24, 1998)

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