TOKUYAMA REBASE III

GUDID 04548190206629

Liquid

TOKUYAMA DENTAL CORPORATION

Denture reliner, hard
Primary Device ID04548190206629
NIH Device Record Key8c873dc4-2ac5-4736-b9bf-41c32761c38c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTOKUYAMA REBASE III
Version Model Number20662
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104548190206629 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-05
Device Publish Date2019-10-28

On-Brand Devices [TOKUYAMA REBASE III]

04548190206629Liquid
04548190206612Fast, Powder, Light Pink
04548190206605Fast, Kit, Light Pink

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