DEVICE: Phase II (D798PEJF0)
Device Identifier (DI) Information
Phase II
PEJF
Not in Commercial Distribution
PEJF
RELIANCE ORTHODONTIC PRODUCTS INC
PEJF
Not in Commercial Distribution
PEJF
RELIANCE ORTHODONTIC PRODUCTS INC
Phase II is intended for use in direct and indirect bonding of orthodontic brackets and appliances.
The highly-filled paste provides a strong mechanical bond with metal and ceramic bracket bases.
Kit contains: 18g Catalyst Paste A with fluoride, 18g Base Paste B, 20g Bonding Resin A with fluoride & B, 23g Liquid Etchant, This is a Fluoride kit with Jar Dispensing.
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.
|
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 [?] |
---|---|
K895523 | 000 |
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
43b74614-4cdb-4cec-9b64-13922408cc1a
July 06, 2018
3
August 06, 2016
July 06, 2018
3
August 06, 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