Dab-Eze® 031145201B

GUDID D813031145201B0

DAB-EZE TENURE S 3g

DEN-MAT HOLDINGS, LLC

Dentine bonding agent/set
Primary Device IDD813031145201B0
NIH Device Record Keyb15f10df-696b-4e70-b380-eaaa97bfc1f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameDab-Eze®
Version Model Number031145201B
Catalog Number031145201B
Company DUNS809857704
Company NameDEN-MAT HOLDINGS, LLC
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

Customer Support Contacts

Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD813031145201B0 [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 Number4
Public Version Date2018-07-06
Device Publish Date2016-09-24

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Trademark Results [Dab-Eze]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DAB-EZE
DAB-EZE
74194234 1701618 Dead/Cancelled
DEN-MAT HOLDINGS, LLC
1991-08-13

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