Palfique Estelite LV

GUDID 04548190123162

Low Flow A1

TOKUYAMA DENTAL CORPORATION

Dental composite resin
Primary Device ID04548190123162
NIH Device Record Keyf5332949-ead6-422c-ba37-a04fcab94c05
Commercial Distribution StatusIn Commercial Distribution
Brand NamePalfique Estelite LV
Version Model Number12316
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
GS104548190123162 [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 [Palfique Estelite LV ]

04548190123247Medium Flow A3.5
04548190123230Medium Flow A3
04548190123223Medium Flow A2
04548190123216Medium Flow A1
04548190123186Low Flow A3
04548190123179Low Flow A2
04548190123162Low Flow A1
04548190123131High Flow A3
04548190123124High Flow A2
04548190123117High Flow A1

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