ESTELITE UNIVERSAL FLOW

GUDID 04548190139767

High PLT A2

TOKUYAMA DENTAL CORPORATION

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin
Primary Device ID04548190139767
NIH Device Record Keyb552fdec-4e64-4f54-8c10-18a2f3dda56b
Commercial Distribution StatusIn Commercial Distribution
Brand NameESTELITE UNIVERSAL FLOW
Version Model Number13976
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104548190139767 [Primary]
GS194548190139760 [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 Date2018-09-10
Device Publish Date2018-08-09

On-Brand Devices [ESTELITE UNIVERSAL FLOW]

04548190139996SuperLow PLT A5
04548190139989SuperLow PLT A4
04548190139972SuperLow PLT A3.5
04548190139965SuperLow PLT A3
04548190139958SuperLow PLT A2
04548190139941SuperLow PLT A1
04548190139934Medium PLT BW
04548190139927Medium PLT CE
04548190139910Medium PLT OPA4
04548190139903Medium PLT OPA3
04548190139897Medium PLT OPA2
04548190139880Medium PLT B3
04548190139873Medium PLT A5
04548190139866Medium PLT A4
04548190139859Medium PLT A3.5
04548190139842Medium PLT A3
04548190139835Medium PLT A2
04548190139828Medium PLT A1
04548190139811High PLT OPA4
04548190139804High PLT OPA3
04548190139798High PLT OPA2
04548190139781High PLT A3.5
04548190139774High PLT A3
04548190139767High PLT A2
04548190139750High PLT A1
04548190138999SuperLow L-SYR A5
04548190138982SuperLow L-SYR A4
04548190138975SuperLow L-SYR A3.5
04548190138968SuperLow L-SYR A3
04548190138951SuperLow L-SYR A2
04548190138944SuperLow L-SYR A1
04548190138937Medium L-SYR BW
04548190138920Medium L-SYR CE
04548190138913Medium L-SYR OPA4
04548190138906Medium L-SYR OPA3
04548190138890Medium L-SYR OPA2
04548190138883Medium L-SYR B3
04548190138876Medium L-SYR A5
04548190138869Medium L-SYR A4
04548190138852Medium L-SYR A3.5
04548190138845Medium L-SYR A3
04548190138838Medium L-SYR A2
04548190138821Medium L-SYR A1
04548190138814High L-SYR OPA4
04548190138807High L-SYR OPA3
04548190138791High L-SYR OPA2
04548190138784High L-SYR A3.5
04548190138777High L-SYR A3
04548190138760High L-SYR A2
04548190138753High L-SYR A1

Trademark Results [ESTELITE UNIVERSAL FLOW]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ESTELITE UNIVERSAL FLOW
ESTELITE UNIVERSAL FLOW
79190057 5178696 Live/Registered
TOKUYAMA CORPORATION
2016-05-12

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