DEVICE: Light Bond (D798LBEBTF0)
Device Identifier (DI) Information
Light Bond
LBEBTF
Not in Commercial Distribution
LBEBTF
RELIANCE ORTHODONTIC PRODUCTS INC
LBEBTF
Not in Commercial Distribution
LBEBTF
RELIANCE ORTHODONTIC PRODUCTS INC
Light Bond is intended for use as a light cure bracket and lingual retainer adhesive.
Light Bond™ will bond to any enamel, porcelain, composite or metal surface, when properly conditioned.
This kit contains 20g of Light Bond Blue Adhesive tips, 2 X 3cc Light Bond Sealans, 1 X 23g liquid etchant and mixing accessories. This kit contains fluoride.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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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? |
---|---|---|---|---|
31750 | Orthodontic bracket adhesive |
A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. 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 [?] |
---|---|
K895522 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store at room temperature (15-30 Degrees C). Avoid excessive heat. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a6864cd3-43d6-47a0-ab60-89045cf4e308
July 06, 2018
3
August 08, 2016
July 06, 2018
3
August 08, 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 |
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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