EDS Self Etch Bonding Agent 900-00

GUDID 00766054000341

Self Etch Bonding Agent

ESSENTIAL DENTAL SYSTEMS, INC.

Dentine bonding agent/set
Primary Device ID00766054000341
NIH Device Record Key09e1449a-13ad-4622-9c40-8391d5e45695
Commercial Distribution StatusIn Commercial Distribution
Brand NameEDS Self Etch Bonding Agent
Version Model Number900-00
Catalog Number900-00
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

Device Dimensions

Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume5 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100766054000341 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAGENT, TOOTH BONDING, 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 Date2017-02-01

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00766054000617 - Tango-Endo2020-07-27 Tango-Endo Intro Kit 25mm
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