Data / Medical devices / Japan / TOKUYAMA DENTAL CORPORATION Kashima Factory
TOKUYAMA DENTAL CORPORATION Kashima Factory: FDA-registered device maker in Kamisu-shi Ibaraki, Japan, 18 510(k) clearances
TOKUYAMA DENTAL CORPORATION Kashima Factory is registered with the FDA (registration 3003621174) in Kamisu-shi Ibaraki, Japan. It lists 7 device types. The FDA files 18 510(k) clearances under its listings, the newest dated May 25, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3003621174
- Address
- 26, Sunayama, Kamisu-shi Ibaraki, Japan, 314-0255
- Owner or operator
- TOKUYAMA DENTAL CORPORATION (9000502)
- Roles
- Manufacturer
- First device listed
- March 14, 2003
- Registered through
- 2026
- Brand names listed
- Brush No. 24, Cement Mixing Tip, Disposable Applicator Tip and Handle, E-1 Esthetic Composite System, ESTECEM, ESTECEM II, Estelite Bulk Fill Flow, Estelite Color and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Tooth Bonding, Resin | KLE | 2 | Manufacturer | accessdata.fda.gov |
| Applicator, Resin | KXR | 1 | Manufacturer | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Manufacturer | accessdata.fda.gov |
| Varnish, Cavity | LBH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 25, 2021 | K203760 | Tokuyama Universal Bond II | KLE | Substantially Equivalent | Tokuyama Dental Corporation | accessdata.fda.gov |
| February 3, 2021 | K203598 | Omnichroma Flow Bulk | EBF | Substantially Equivalent | Tokuyama Dental Corporation | accessdata.fda.gov |
| August 19, 2020 | K193537 | Omnichroma Flow | EBF | Substantially Equivalent | Tokuyama Dental Corporation | accessdata.fda.gov |
| October 4, 2019 | K190940 | Tokuyama Rebase III | EBI | Substantially Equivalent | Tokuyama Dental Corporation | accessdata.fda.gov |
| July 12, 2018 | K180613 | Estelite Universal Flow | EBF | Substantially Equivalent | Tokuyama Dental Corporation | accessdata.fda.gov |
| February 27, 2018 | K173275 | OMNICHROMA | EBF | Substantially Equivalent | Tokuyama Dental Corporation | accessdata.fda.gov |
| November 28, 2017 | K171226 | TOKUYAMA UNIVERSAL BOND | KLE | Substantially Equivalent | Tokuyama Dental Corporation | accessdata.fda.gov |
| April 3, 2017 | K161353 | ESTELITE BULK FILL Flow | EBF | Substantially Equivalent | Tokuyama Dental Corporation | accessdata.fda.gov |
| June 17, 2015 | K150727 | ESTECEM | EMA | Substantially Equivalent | Tokuyama Dental Corporation | accessdata.fda.gov |
| October 28, 2011 | K112445 | SOFRELINER TOUGH S | EBI | Substantially Equivalent | Tokuyama Dental Corporation | accessdata.fda.gov |
| April 5, 2011 | K110178 | ESTELITE COLOR | EBF | Substantially Equivalent | Tokuyama Dental Corporation | accessdata.fda.gov |
| October 21, 2010 | K100172 | TOKUYAMA SHIELD FORCE | LBH | Substantially Equivalent | Tokuyama Dental Corporation | accessdata.fda.gov |
| June 19, 2008 | K080940 | ESTELITE SIGMA QUICK | EBF | Substantially Equivalent | Tokuyama Dental Corporation | accessdata.fda.gov |
| December 4, 2007 | K072746 | E-1 ESTHETIC COMPOSITE SYSTEM | EBF | Substantially Equivalent | Tokuyama Dental Corporation | accessdata.fda.gov |
| March 30, 2007 | K070215 | TOKUYAMA BOND FORCE | KLE | Substantially Equivalent | Tokuyama Dental Corporation | accessdata.fda.gov |
| May 29, 2003 | K030663 | TOKUYAMA SOFRELINER TOUGH | EBI | Substantially Equivalent | Tokuyama Dental Corporation | accessdata.fda.gov |
| February 2, 2000 | K993917 | TOKUYAMA ONE-UP-BOND F | KLE | Substantially Equivalent | Tokuyama America, Inc. | accessdata.fda.gov |
| October 7, 1997 | K973245 | TOKUSO REBASE MR. BOND | KLE | Substantially Equivalent | Tokuyama America, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Material, Tooth Shade, Resin
- All makers of Applicator, Resin
- All makers of Syringe, Restorative And Impression Material
- All makers of Cement, Dental
- All makers of Agent, Tooth Bonding, Resin
Updated May 25, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.