EZ-Fill Xpress 1620-00

GUDID 00766054000167

Root Canal Xpress Cement Syringeable with Bi-Directional Spirals Stainless Steel

ESSENTIAL DENTAL SYSTEMS, INC.

Endodontic filling/sealing material
Primary Device ID00766054000167
NIH Device Record Key411dd56a-6cd9-4490-9a65-48ec48ec844e
Commercial Distribution StatusIn Commercial Distribution
Brand NameEZ-Fill Xpress
Version Model Number1620-00
Catalog Number1620-00
Company DUNS101147171
Company NameESSENTIAL DENTAL SYSTEMS, INC.
Device Count1
DM Exempttrue
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com
Phone+1(201)487-9090
Emailudi@edsdental.com

Device Dimensions

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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100766054000167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KIFRESIN, ROOT CANAL FILLING

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00766054000167]

Moist Heat or Steam Sterilization


[00766054000167]

Moist Heat or Steam Sterilization


[00766054000167]

Moist Heat or Steam Sterilization


[00766054000167]

Moist Heat or Steam Sterilization


[00766054000167]

Moist Heat or Steam Sterilization


[00766054000167]

Moist Heat or Steam Sterilization


[00766054000167]

Moist Heat or Steam Sterilization


[00766054000167]

Moist Heat or Steam Sterilization


[00766054000167]

Moist Heat or Steam Sterilization


[00766054000167]

Moist Heat or Steam Sterilization


[00766054000167]

Moist Heat or Steam Sterilization


[00766054000167]

Moist Heat or Steam Sterilization


[00766054000167]

Moist Heat or Steam Sterilization


[00766054000167]

Moist Heat or Steam Sterilization


[00766054000167]

Moist Heat or Steam Sterilization


[00766054000167]

Moist Heat or Steam Sterilization


[00766054000167]

Moist Heat or Steam Sterilization


[00766054000167]

Moist Heat or Steam Sterilization


[00766054000167]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-01

On-Brand Devices [EZ-Fill Xpress]

00766054000174Root Canal Xpress Cement Syringeable with Bi-Directional Spirals Nickel Titanium
00766054000167Root Canal Xpress Cement Syringeable with Bi-Directional Spirals Stainless Steel

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