# Tokuyama Dental Corporation

- Location (FDA's records): Tokyo, JP
- FDA decisions: 19 (2003–2021): 19 510(k) clearances
- Product codes: EBF (9), EBI (5), KLE (3), LBH (1), EMA (1)
- 510(k) review time since 2016: median 153 days, against 163 for FDA's reviews in the same codes and years (3 of 9 faster)
- Predicates its devices cite: 31 (14 its own); citations of its devices by later devices: 18 (14 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
- Tokuyama America, Inc.: 8 (https://510kreport.com/company/tokuyama-america)
- GC America, Inc.: 4 (https://510kreport.com/company/gc-america)
- Austenal, Inc.: 1 (https://510kreport.com/company/austenal)
- 3M Espe AG: 1 (https://510kreport.com/company/3m-espe)
- Voco GmbH: 1 (https://510kreport.com/company/voco)
- Kuraray Medical, Inc.: 1 (https://510kreport.com/company/kuraray-medical)
- Sybron Dental Specialties, Inc.: 1 (https://510kreport.com/company/sybron-dental-specialties)

## Firms that cite its devices most
- Spident Co., Ltd.: 2 (https://510kreport.com/company/spident)
- Meta Biomed Co., Ltd.: 1 (https://510kreport.com/company/meta-biomed)
- DiaDent Group International: 1 (https://510kreport.com/company/diadent-group-international)

## Its most-cited devices
- K051808: Estelite Flow Quick (2005), cited by 4
- K173275: Omnichroma (2018), cited by 2
- K161353: ESTELITE BULK FILL Flow (2017), cited by 2
- K070215: Tokuyama Bond Force (2007), cited by 2
- K080940: Estelite Sigma Quick (2008), cited by 2
- K072746: E-1 Esthetic Composite System (2007), cited by 1

## Recent decisions
- K203760: Tokuyama Universal Bond II (May 25, 2021)
- K203598: Omnichroma Flow Bulk (Feb 3, 2021)
- K193537: Omnichroma Flow (Aug 19, 2020)
- K190940: Tokuyama Rebase III (Oct 4, 2019)
- K180613: Estelite Universal Flow (Jul 12, 2018)
- K173275: Omnichroma (Feb 27, 2018)
- K171226: Tokuyama Universal Bond (Nov 28, 2017)
- K170549: Tokuyama Curegrace (Jul 5, 2017)

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