DEVICE: Phase II (D798PSF0)

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Device Record History
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Device Identifier (DI) Information
Phase II
PSF
In Commercial Distribution
PSF
RELIANCE ORTHODONTIC PRODUCTS INC
D798PSF0
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 with fluoride, 18g Base Paste B, 7g Bonding Resin A with fluoride &B, 9g Liquid Etchant, mixing pad, spatulas, disposable brushes. This is a Fluoride 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?
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
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
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
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FDA Product Code

[?]
Product Code Product Code Name
DYH Adhesive, Bracket And Tooth Conditioner, Resin
KLE Agent, Tooth Bonding, 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
77400d6b-2c32-45f8-97c1-85849646689b
February 16, 2024
4
August 19, 2016
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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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