Assure Universal Bonding Resin AS2ML

GUDID D798AS2ML0

Assure® Universal Bonding Resin is hydrophilic so the etched enamel can be dry or slightly contaminated with saliva. Assure® Universal Bonding Resin does not require light activation (except on dentin). It can be used under any chemical, light cure or dual cure paste, regardless of manufacturer. .

RELIANCE ORTHODONTIC PRODUCTS INC

Dentine bonding agent/set
Primary Device IDD798AS2ML0
NIH Device Record Key73a65127-8090-46c4-a7e0-c1aea74dcbc9
Commercial Distribution StatusIn Commercial Distribution
Brand NameAssure Universal Bonding Resin
Version Model NumberAS2ML
Catalog NumberAS2ML
Company DUNS113170088
Company NameRELIANCE ORTHODONTIC PRODUCTS INC
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

Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD798AS2ML0 [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 Number4
Public Version Date2018-10-29
Device Publish Date2016-07-13

On-Brand Devices [Assure Universal Bonding Resin]

D798BI4MLAS0Assure® Universal Bonding Resin is hydrophilic so the etched enamel can be dry or slightly cont
D798AS2ML0Assure® Universal Bonding Resin is hydrophilic so the etched enamel can be dry or slightly cont
00840479200897BI4MLAS
00840479200767AS

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