DEVICE: Assure Universal Bonding Resin (D798BI4MLAS0)
Device Identifier (DI) Information
Assure Universal Bonding Resin
BI4MLAS
In Commercial Distribution
BI4MLAS
RELIANCE ORTHODONTIC PRODUCTS INC
BI4MLAS
In Commercial Distribution
BI4MLAS
RELIANCE ORTHODONTIC PRODUCTS INC
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.
This is the 4 gm volume.
.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
34782 | Dentine bonding agent/set |
A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KLE | Agent, Tooth Bonding, Resin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C). |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
33c35d43-61ec-4ded-a48b-6d81722dd7c7
February 16, 2024
2
August 10, 2018
February 16, 2024
2
August 10, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
6307734009
paulgropi@aol.com
paulgropi@aol.com