EON

GUDID 00366975002587

E-ON SELF ETCH LC BOND AGENT

BENCO DENTAL SUPPLY CO.

Dentine adhesive
Primary Device ID00366975002587
NIH Device Record Key078c5d25-9678-49fa-a140-6c59389b5e0b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEON
Version Model Number4601-914
Company DUNS015108087
Company NameBENCO DENTAL SUPPLY CO.
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100366975002587 [Primary]

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 Number2
Public Version Date2018-03-29
Device Publish Date2016-09-23

On-Brand Devices [EON]

00366975013330Eon Desensitizer without Glutaraldehyde
00366975013323Eon Desensitizer with Glutaraldehyde
00366975002594E-ON TOTAL cement , dental
00366975002587E-ON SELF ETCH LC BOND AGENT
003669750362305522-025

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