DEVICE: Rely.a.Bond (D798RPTHIN0)
Device Identifier (DI) Information
Rely.a.Bond
RPTHIN
Not in Commercial Distribution
RPTHIN
RELIANCE ORTHODONTIC PRODUCTS INC
RPTHIN
Not in Commercial Distribution
RPTHIN
RELIANCE ORTHODONTIC PRODUCTS INC
Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic brackets.
This Rely A Bond Thin Viscosity Kit Contains: 14g Adhesive Thin Adhesive Paste push syringes, 16g Primer Non-Fluoride, 9gm etchant liquid, mixing pad, spatulas and brushes. This kit in Non-Fluoride
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
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 [?] |
---|---|
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) |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
dacdcef1-7767-42ad-8202-c3e4a73985d4
March 29, 2018
2
August 17, 2016
March 29, 2018
2
August 17, 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
[?]
6307734009
paulgropi@aol.com
paulgropi@aol.com