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Sign in to claim this brandTOKUYAMA DENTAL CORPORATION
US
Last updated May 24, 2026
What TOKUYAMA DENTAL CORPORATION makes
Tokuyama Dental Corporation manufactures dental composite resins, including shade-matched filling materials like Estelite Color and Estelite Flow Quick, designed for direct restorations. Their portfolio also includes hard and elastic denture reliners, such as Sofreliner Tough and TOKUYAMA REBASE, for repairing or extending denture life, as well as dentine adhesives and bonding agents like Bistite II DC and Tokuyama Bond Force. The company produces dental materials like cavity varnish and single-use injection cannulas for precise application, alongside mixing nozzles for composite resins.
The company’s devices are regulated under the FDA as Class I and Class II medical devices, with submissions documented through 510(k) clearances and listed in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use in dental procedures in the United States, adhering to regulatory requirements for restorative and prosthetic materials.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- tokuyama-us.com
- —
- —
- [email protected]
- Phone
- 1-877-378-3548
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 693552176
Catalogue (297)
Page 3 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Estelite Sigma Quick | 13324 | FDA UDI | Class II | Active |
| Estelite Universal Flow | 13876 | FDA UDI | Class II | Active |
| Estelite Omega | 10728 | FDA UDI | Class II | Active |
| Estelite Color | 10922 | FDA UDI | Class II | Active |
| Estelite Flow Quick | 12022 | FDA UDI | Class II | Active |
| Estecem Ii | 16188 | FDA UDI | Class II | Active |
| Estelite Sigma Quick | 13314 | FDA UDI | Class II | Active |
| Estelite Omega | 10730 | FDA UDI | Class II | Active |
| Estelite Flow Quick | 12126 | FDA UDI | Class II | Active |
| Estelite Sigma Quick | 13381 | FDA UDI | Class II | Active |
| Tokuyama Rebase II | 20563 | FDA UDI | Class II | Active |
| Estelite Universal Flow | 13890 | FDA UDI | Class II | Active |
| Estelite Universal Flow | 13892 | FDA UDI | Class II | Active |
| Estelite Universal Flow | 13981 | FDA UDI | Class II | Active |
| BIstite II DC | 16337 | FDA UDI | Class II | Active |
| Estelite Color | 10923 | FDA UDI | Class II | Active |
| Estelite Omega | 10701 | FDA UDI | Class II | Active |
| Estelite Sigma Quick | 13113 | FDA UDI | Class II | Active |
| Sofreliner Tough | 23411 | FDA UDI | Class II | Active |
| Estelite Flow Quick | 12028 | FDA UDI | Class II | Active |
| Estelite Sigma Quick | 13127 | FDA UDI | Class II | Active |
| Omnichroma Flow | 10224 | FDA UDI | Class II | Active |
| Estelite Universal Flow | 13975 | FDA UDI | Class II | Active |
| Estelite Universal Flow | 13891 | FDA UDI | Class II | Active |
| Tokuyama Rebase Iii | 20660 | FDA UDI | Class II | Active |
| One-UP Bond F Plus | 14737 | FDA UDI | Class II | Active |
| Estelite Color | 10921 | FDA UDI | Class II | Active |
| Estelite Flow Quick | 12116 | FDA UDI | Class II | Active |
| Estelite Color | 10915 | FDA UDI | Class II | Active |
| Estelite Bulk Fill Flow | 12737 | FDA UDI | Class II | Active |
| Estelite Sigma Quick | 13318 | FDA UDI | Class II | Active |
| Omnichroma | 10132 | FDA UDI | Class II | Active |
| Omnichroma Flow Bulk | 10221 | FDA UDI | Class II | Active |
| Estecem Ii | 16168 | FDA UDI | Class II | Active |
| Estelite Bulk Fill Flow | 12744 | FDA UDI | Class II | Active |
| Estelite Color | 10918 | FDA UDI | Class II | Active |
| Estelite Universal Flow | 13897 | FDA UDI | Class II | Active |
| Estelite Flow Quick | 12112 | FDA UDI | Class II | Active |
| Tokuyama Bond Force | 14912 | FDA UDI | Class II | Active |
| Estelite Bulk Fill Flow | 12736 | FDA UDI | Class II | Active |
| Estelite Universal Flow | 13896 | FDA UDI | Class II | Active |
| Estelite Flow Quick | 12117 | FDA UDI | Class II | Active |
| Sofreliner Tough | 23401 | FDA UDI | Class II | Active |
| One-UP Bond F Plus | 14706 | FDA UDI | Class II | Active |
| Estelite Flow Quick | 12122 | FDA UDI | Class II | Active |
| Estelite Universal Flow | 13877 | FDA UDI | Class II | Active |
| Estelite Color | 10912 | FDA UDI | Class II | Active |
| Estelite Sigma Quick | 13114 | FDA UDI | Class II | Active |
| Estelite Omega | 10751 | FDA UDI | Class II | Active |
| Estelite Sigma Quick | 13125 | FDA UDI | Class II | Active |
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