Estelite Bulk Fill Flow

GUDID 04548190127351

PLT U

TOKUYAMA DENTAL CORPORATION

Dental composite resin
Primary Device ID04548190127351
NIH Device Record Key1a9271d9-818b-4cef-9ac6-2574a875450f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEstelite Bulk Fill Flow
Version Model Number12735
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
GS104548190127351 [Primary]
GS194548190127354 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-01

On-Brand Devices [Estelite Bulk Fill Flow]

04548190127443PLT Mini Kit
04548190127399PLT A3
04548190127382PLT A2
04548190127375PLT A1
04548190127368PLT B1
04548190127351PLT U
04548190127191Syringe A3
04548190127184Syringe A2
04548190127177Syringe A1
04548190127160Syringe B1
04548190127153Syringe U

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