DEVICE: Bonding Resin (D798S7AF0)
Device Identifier (DI) Information
Bonding Resin
S7AF
In Commercial Distribution
S7AF
RELIANCE ORTHODONTIC PRODUCTS INC
S7AF
In Commercial Distribution
S7AF
RELIANCE ORTHODONTIC PRODUCTS INC
Reliance Bonding Resins are intended for use in direct and indirect bonding of orthodontic brackets and appliances. 7g bottle sealant resin A with Fluoride.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
No | |
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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 |
---|---|
DYH | Adhesive, Bracket And Tooth Conditioner, Resin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K894565 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store at room temperature (15-30 ◦C) |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
342f7ec2-c3f4-4c75-a5ba-5f447b3bbec3
February 16, 2024
4
August 01, 2016
February 16, 2024
4
August 01, 2016
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
[?]
630-773-4009
paulgropi@aol.com
paulgropi@aol.com