DEVICE: Phase II (D798EUPS0)

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Device Record History
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Device Identifier (DI) Information
Phase II
EUPS
In Commercial Distribution
EUPS
RELIANCE ORTHODONTIC PRODUCTS INC
D798EUPS0
HIBCC

1
113170088 *Terms of Use
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, 18g Base Paste B, 7g Bonding Resin A with fluoride &B, 9g Liquid Etchant, mixing pad, spatulas, disposable brushes. This is a kit with Screw Syringe Dispensing.
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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
36153 Dental etching solution
An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.
Active false
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KLE Agent, Tooth Bonding, Resin
DYH Adhesive, Bracket And Tooth Conditioner, Resin
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Storage at room temperature (15-30 Degrees C)
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
0b17dd47-edad-483c-aa45-e5772d2842e1
February 16, 2024
3
November 11, 2018
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
6307734009
paulgropi@aol.com
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