Estelite Color

GUDID 04548190109203

Pink Opaque

TOKUYAMA DENTAL CORPORATION

Dental composite resin
Primary Device ID04548190109203
NIH Device Record Key00993054-c18b-4b80-8815-d78d5a19a506
Commercial Distribution StatusIn Commercial Distribution
Brand NameEstelite Color
Version Model Number10920
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
GS104548190109203 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [Estelite Color ]

04548190109234Low Chroma Opaque
04548190109227Medium Chroma Opaque
04548190109210High Chroma Opaque
04548190109203Pink Opaque
04548190109197Lavender
04548190109180Red
04548190109173Dark Brown
04548190109166Ochre
04548190109159Gray
04548190109142Yellow
04548190109135Blue
04548190109128White
04548190109111Clear
04548190109012Kit

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