OMNICHROMA

GUDID 04548190101269

PLT

TOKUYAMA DENTAL CORPORATION

Dental composite resin
Primary Device ID04548190101269
NIH Device Record Key8caeac50-d3f6-4e34-8f10-d1d2e7ec0c54
Commercial Distribution StatusIn Commercial Distribution
Brand NameOMNICHROMA
Version Model Number10126
Company DUNS693552176
Company NameTOKUYAMA DENTAL CORPORATION
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS104548190101269 [Primary]
GS194548190101262 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-11
Device Publish Date2018-09-10

On-Brand Devices [OMNICHROMA]

04548190101511PLT SAMPLE KIT
04548190101412SYRINGE SAMPLE KIT
04548190101320Syringe Sample
04548190101306PLT Sample
04548190101269PLT
04548190101160SYRINGE

Trademark Results [OMNICHROMA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OMNICHROMA
OMNICHROMA
79259714 5946969 Live/Registered
TOKUYAMA CORPORATION
2019-03-11
OMNICHROMA
OMNICHROMA
79212364 5477779 Live/Registered
TOKUYAMA CORPORATION
2017-02-27

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