Manufacturer registered with FDA
Tokuyama Dental Corporation
Taitou-ku, Japan. Lists 7 dental device types with FDA across 1 registered establishment, and holds 19 510(k) clearances as applicant.
- Device types listed
- 7
- Brands and models
- 36
- 510(k) clearances
- 192003–2021
- Markets registered in
- 13304 registrations outside the US
- Establishments
- 1Japan
510(k) clearances per year, 2000–2026
Registered in 13 markets
Where regulators' registries name Tokuyama Dental Corporation as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Tokuyama Dental Corporation | 19 clearances | 2003–2021 | Below |
| Canada | Health Canada | Registration holder | TOKUYAMA DENTAL CORPORATION | 168 | 1998–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Tokuyama Dental Corporation Kashima FactoryTOKUYAMA DENTAL CORP. · TOKUYAMA DENTAL CORP · +1 | 34 | 1999–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | TOKUYAMA DENTAL CORPORATION KASHIMA FACTORY | 30 | 2004–2025 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Tokuyama Dental Corporation | 20 | 2022–2025 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | TOKUYAMA DENTAL CORPORATION | 13 | 2016–2024 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | TOKUYAMA DENTAL CORPORATION | 12 | 2009–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | Tokuyama Dental Corporation | 9 | 2004–2017 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Tokuyama Dental Corporation | 7 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | TOKUYAMA DENTAL CORPORATIONTOKUYAMA DENTAL CORPORATION KASHIMA FACTORY | 4 | — | Pure Global AI |
| Philippines | FDA Philippines | Manufacturer | Tokuyama Dental Corporation | 3 | 2025–2025 | Pure Global AI |
| China | NMPA | Registration holder | 德山牙科株式会社Tokuyama Dental Corporation | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Tokuyama Dental Corporation | 2 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Tokuyama Dental Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | E-1 Esthetic Composite SystemEstelite Bulk Fill FlowEstelite ColorEstelite OmegaEstelite Sigma QuickEstelite Universal FlowOMNICHROMAOMNICHROMA BLOCKEROMNICHROMA BLOCKER FLOWOMNICHROMA FLOW 2 moreOMNICHROMA FLOW BULKPalfique LX5 | 2007 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | Estelite Sigma Introductory KitOne-Up Bond F PlusTokuso Rebase Mr. BondTokuyama Bond ForceTokuyama One-Up Bond FTokuyama Universal BondTOKUYAMA UNIVERSAL BOND II | 2008 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Sofreliner ToughSofreliner Tough STOKUYAMA REBASE III | 2008 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Cement Mixing TipDisposable Applicator Tip and HandleMini Mixing Tip SNozzle for Mini Mixing TipPalfique Estelite LV Syringe TipTD II DispenserTD II Mixing TipTokuyama Dispensing TipTokuyama Plastic Tip | 2003 |
| Dental CementEMA · Class 2 | Dental cements | Maker | ESTECEMESTECEM II | 2015 |
| Resin ApplicatorKXR · Class 1 | — | Maker | Brush No. 24 | 2011 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | TOKUYAMA SHIELD FORCETOKUYAMA SHIELD FORCE PLUS | 2010 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Tokuyama Dental Corporation as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 25 May 2021 | K203760 | Tokuyama Universal Bond II | KLE Resin Tooth Bonding Agent |
| 3 Feb 2021 | K203598 | Omnichroma Flow Bulk | EBF Resin Tooth Shade Material |
| 19 Aug 2020 | K193537 | Omnichroma Flow | EBF Resin Tooth Shade Material |
| 4 Oct 2019 | K190940 | Tokuyama Rebase III | EBI Rebasing Repairing Relining Denture Resin |
| 12 Jul 2018 | K180613 | Estelite Universal Flow | EBF Resin Tooth Shade Material |
| 27 Feb 2018 | K173275 | OMNICHROMA | EBF Resin Tooth Shade Material |
| 28 Nov 2017 | K171226 | TOKUYAMA UNIVERSAL BOND | KLE Resin Tooth Bonding Agent |
| 5 Jul 2017 | K170549 | TOKUYAMA CUREGRACE | EBI Rebasing Repairing Relining Denture Resin |
| 3 Apr 2017 | K161353 | ESTELITE BULK FILL Flow | EBF Resin Tooth Shade Material |
| 17 Jun 2015 | K150727 | ESTECEM | EMA Dental Cement |
| 28 Oct 2011 | K112445 | SOFRELINER TOUGH S | EBI Rebasing Repairing Relining Denture Resin |
| 5 Apr 2011 | K110178 | ESTELITE COLOR | EBF Resin Tooth Shade Material |
| 21 Oct 2010 | K100172 | TOKUYAMA SHIELD FORCE | LBH Cavity Varnish |
| 18 Mar 2009 | K081554 | TOKUYAMA TISSUECARE | EBI Rebasing Repairing Relining Denture Resin |
| 19 Jun 2008 | K080940 | ESTELITE SIGMA QUICK | EBF Resin Tooth Shade Material |
| 4 Dec 2007 | K072746 | E-1 ESTHETIC COMPOSITE SYSTEM | EBF Resin Tooth Shade Material |
| 30 Mar 2007 | K070215 | TOKUYAMA BOND FORCE | KLE Resin Tooth Bonding Agent |
| 8 Aug 2005 | K051808 | ESTELITE FLOW QUICK | EBF Resin Tooth Shade Material |
| 29 May 2003 | K030663 | TOKUYAMA SOFRELINER TOUGH | EBI Rebasing Repairing Relining Denture Resin |
Some of these clearances are listed with FDA today by another company: Zest Anchors, LLC (1).
Also lists devices cleared under other names
Tokuyama Dental Corporation lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Tokuyama America, Inc. (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 2 Feb 2000 | K993917 | TOKUYAMA ONE-UP-BOND F | Tokuyama America, Inc. | KLE Resin Tooth Bonding Agent |
| 7 Oct 1997 | K973245 | TOKUSO REBASE MR. BOND | Tokuyama America, Inc. | KLE Resin Tooth Bonding Agent |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| TOKUYAMA DENTAL CORPORATION Kashima FactoryFDA reg. 3003621174 | Kamisu-shi Ibaraki, Japan | Manufacturer |
Other names on FDA records
Tokuyama Dental Corporation Kashima Factory
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9000502). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.