Tokuyama Rebase II

GUDID 04548190205462

Powder, Fast, Light Pink

TOKUYAMA DENTAL CORPORATION

Denture reliner, hard
Primary Device ID04548190205462
NIH Device Record Keyad5c8558-c6a8-417d-901b-ea1f1e92f4c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameTokuyama Rebase II
Version Model Number20546
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
GS104548190205462 [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 [Tokuyama Rebase II ]

04548190205639Adhesive
04548190205622Liquid, Fast
04548190205462Powder, Fast, Light Pink
04548190205066Kit, Fast, Light Pink

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