EON

GUDID 00366975013323

Eon Desensitizer with Glutaraldehyde

BENCO DENTAL SUPPLY CO.

Dental coating, tooth-desensitizing
Primary Device ID00366975013323
NIH Device Record Keyd19c7dd8-407a-4d64-a0db-f5085e609f3a
Commercial Distribution StatusIn Commercial Distribution
Brand NameEON
Version Model Number5146-567
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 Usetrue
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

Phone570-602-6924
Emailjsoroka@benco.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100366975013323 [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 Date2019-02-07
Device Publish Date2018-06-04

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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