OMNICHROMA BLOCKER FLOW

GUDID 04548190102228

SYRINGE

TOKUYAMA DENTAL CORPORATION

Dental composite resin
Primary Device ID04548190102228
NIH Device Record Key3a80c2f2-94ab-49ee-8547-22df3a1ebd72
Commercial Distribution StatusIn Commercial Distribution
Brand NameOMNICHROMA BLOCKER FLOW
Version Model Number10222
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
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
GS104548190102228 [Primary]

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 Date2020-04-08
Device Publish Date2020-03-31

Devices Manufactured by TOKUYAMA DENTAL CORPORATION

04548190102242 - OMNICHROMA FLOW2024-11-04 SYRINGE SAMPLE KIT
04548190107629 - Brush No.242022-10-03 Brush for composite
94548190122717 - PALFIQUE ESTELITE LV Syringe Tip2022-10-03 Dispensing tip for flowable composite
04548190127405 - TOKUYAMA Dispensing Tip2022-10-03 Dispensing tip for flowable composite
94548190137995 - TOKUYAMA Plastic Tip2022-10-03 Plastic dispensing tip for flowable composite
04548190146727 - Disposable Applicator Tip & Handle Set2022-10-03 Disposable Applicator Tip & Handle for One-Up Bond F Plus
94548190161938 - Cement Mixing Tip2022-10-03 Mixing tip for cement
04548190233724 - TOKUYAMA DISPENSER II2022-10-03 Dispensor for Sofreliner

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