FDA Registration Active 🇯🇵 Japan

TOKUYAMA DENTAL CORPORATION Kashima Factory

Reg #: 3003621174 · FEI: 3003621174 · Expires 2026
Products
7
Proprietary Names
36
Establishment Types
1
Classifications
7

Registration Details

Registration Name
TOKUYAMA DENTAL CORPORATION Kashima Factory
Registration Number
3003621174
FEI Number
3003621174
Status
Active
Expiry Year
2026
Initial Importer
No
Address
26, Sunayama
City
Kamisu-shi Ibaraki
Country
JP

Regulatory Submissions

510(k) Number
K203760

Owner / Operator

Firm Name
TOKUYAMA DENTAL CORPORATION
Operator Number
9000502
Address
38-9 Taitou 1-chome
City
Taitou-ku
State
Tokyo
Postal Code
110-0016
Country
JP

US Agent

Business Name
Fish & Richardson P.C.
Contact Name
Keith Barritt
Address
1000 Maine Ave. S.W., Suite 1000
City
WASHINGTON
State
DC
ZIP
20024
Country
US
Phone
202 6266433

Products

Device Name Product Code
Syringe, Restorative And Impression Material EID
Agent, Tooth Bonding, Resin KLE
Resin, Denture, Relining, Repairing, Rebasing EBI
Material, Tooth Shade, Resin EBF
Cement, Dental EMA
Applicator, Resin KXR
Varnish, Cavity LBH

Proprietary Names

Cement Mixing Tip Nozzle for Mini Mixing Tip TD II Dispenser Palfique Estelite LV Syringe Tip TD II Mixing Tip Disposable Applicator Tip and Handle Mini Mixing Tip S Tokuyama Plastic Tip Tokuyama Dispensing Tip TOKUYAMA UNIVERSAL BOND II Sofreliner Tough S TOKUYAMA REBASE III Tokuyama Universal Bond Estelite Color OMNICHROMA BLOCKER FLOW Estelite Universal Flow Tokuyama One-Up Bond F One-Up Bond F Plus Estelite Sigma Introductory Kit Estelite Bulk Fill Flow E-1 Esthetic Composite System Estelite Omega OMNICHROMA FLOW Tokuso Rebase Mr. Bond OMNICHROMA ESTECEM ESTECEM II OMNICHROMA FLOW BULK Brush No. 24 Palfique LX5 Estelite Sigma Quick OMNICHROMA BLOCKER Sofreliner Tough TOKUYAMA SHIELD FORCE PLUS TOKUYAMA SHIELD FORCE Tokuyama Bond Force

Establishment Types

Manufacture Medical Device