EZ-Fill Root Canal Cement 1608-00

GUDID 00766054000143

Root Canal Cement Powder Jar/Gel Tube

ESSENTIAL DENTAL SYSTEMS, INC.

Endodontic filling/sealing material
Primary Device ID00766054000143
NIH Device Record Key0b7922ca-0942-4ee6-bfe8-206cdebcfef7
Commercial Distribution StatusIn Commercial Distribution
Brand NameEZ-Fill Root Canal Cement
Version Model Number1608-00
Catalog Number1608-00
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 Numberfalse
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
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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
GS100766054000143 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KIFRESIN, ROOT CANAL FILLING

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 Date2016-07-01

On-Brand Devices [EZ-Fill Root Canal Cement]

00766054000143Root Canal Cement Powder Jar/Gel Tube
00766054000136Root Canal Cement Powder Jar/Gel Tube with Bi-Directional Spirals Nickel Titanium
00766054000129Root Canal Cement Powder Jar/Gel Tube with Bi-Directional Spirals Stainless Steel

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