Sofreliner Tough

GUDID 04548190233519

M Kit

TOKUYAMA DENTAL CORPORATION

Denture reliner, elastic, long-term
Primary Device ID04548190233519
NIH Device Record Key70cc3afa-fd19-4037-8ea2-3f8001a05bc5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSofreliner Tough
Version Model Number23351
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 Kittrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104548190233519 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-09
Device Publish Date2016-09-23

On-Brand Devices [Sofreliner Tough]

04548190234417Primer
04548190234110S Paste
04548190234011S Kit
04548190233564M Paste
04548190233519M Kit

Trademark Results [Sofreliner Tough]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOFRELINER TOUGH
SOFRELINER TOUGH
76198655 2703676 Live/Registered
Tokuyama Corporation
2001-01-24

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