Tokuyama Universal Bond

GUDID 04548190152131

Bond A

TOKUYAMA DENTAL CORPORATION

Dentine bonding agent/set
Primary Device ID04548190152131
NIH Device Record Key83c4dc59-1a67-44e3-a5a8-2e6174241b21
Commercial Distribution StatusIn Commercial Distribution
Brand NameTokuyama Universal Bond
Version Model Number15213
Company DUNS693552176
Company NameTOKUYAMA DENTAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-877-378-3548
Emailinfo@tokuyama-us.com
Phone1-877-378-3548
Emailinfo@tokuyama-us.com
Phone1-877-378-3548
Emailinfo@tokuyama-us.com
Phone1-877-378-3548
Emailinfo@tokuyama-us.com
Phone1-877-378-3548
Emailinfo@tokuyama-us.com
Phone1-877-378-3548
Emailinfo@tokuyama-us.com
Phone1-877-378-3548
Emailinfo@tokuyama-us.com
Phone1-877-378-3548
Emailinfo@tokuyama-us.com
Phone1-877-378-3548
Emailinfo@tokuyama-us.com
Phone1-877-378-3548
Emailinfo@tokuyama-us.com
Phone1-877-378-3548
Emailinfo@tokuyama-us.com
Phone1-877-378-3548
Emailinfo@tokuyama-us.com
Phone1-877-378-3548
Emailinfo@tokuyama-us.com
Phone1-877-378-3548
Emailinfo@tokuyama-us.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104548190152131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAgent, Tooth Bonding, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-05

On-Brand Devices [Tokuyama Universal Bond]

04548190152186Bond B
04548190152131Bond A
04548190152032Kit
04548190152094Mini Kit

Trademark Results [Tokuyama Universal Bond]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TOKUYAMA UNIVERSAL BOND
TOKUYAMA UNIVERSAL BOND
79191239 5135162 Live/Registered
TOKUYAMA CORPORATION
2016-04-13

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