OMNICHROMA BLOCKER

GUDID 04548190101276

PLT

TOKUYAMA DENTAL CORPORATION

Dental composite resin
Primary Device ID04548190101276
NIH Device Record Keyb46b066d-e52a-40f8-8a13-f18bda04f2cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameOMNICHROMA BLOCKER
Version Model Number10127
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
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
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 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104548190101276 [Primary]
GS194548190101279 [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 BLOCKER]

04548190101337Syringe Sample
04548190101313PLT Sample
04548190101276PLT
04548190101177SYRINGE

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