DEVICE: A2 (D798A20)

Device Identifier (DI) Information

A2
A2
Not in Commercial Distribution
A2
RELIANCE ORTHODONTIC PRODUCTS INC
D798A20
HIBCC
September 07, 2017
1
113170088 *Terms of Use
The aligner attachment kit is intended for use in the creation of molds for thermoplastic alligners. The Oval Attachment Form can be used for the retention of the thermoplastic aligners and for horizontal or vertical placement on the tooth depending on the height of the crown. The Rectangle Attachment Form can be used for individual tooth movement and for extrusion of teeth. The Assure Bonding Resin included will bond to all intraoral surfaces without additional primers. L.C.R. Light Cure Paste cures smooth as glass for patient comfort. It has a very high Barcol Hardness for long term durability.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Orthodontic aligner auxiliary attachment kit A collection of devices, used with retainer-style orthodontic appliances (e.g., preformed teeth aligners) to further facilitate and enhance teeth alignment. The kit includes buttons and elastics, typically made of clear materials for aesthetic purposes, that are attached to the orthodontic aligner and/or teeth to help achieve extrusion, rotation and anchorage control. This provides the clinician with greater control to achieve additional tooth movement during the treatment. The contents of this kit may also include plastic/composite adhesive, etchant, elastics, burs and polishing wheels for cutting the aligners. This is a reusable device.
Dental mould A hollow form in which a dental material is intended to be injected, cast, or pressed to produce a particular shape.
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 includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. After application, this device cannot be reused.
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FDA Product Code

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Product Code Product Code Name
KLE Agent, Tooth Bonding, Resin
EBI Resin, Denture, Relining, Repairing, Rebasing
KXR Applicator, Resin
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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

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Storage and Handling
Special Storage Condition, Specify: Store at room temperature
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

9a1f6d38-02c2-4840-b76a-ae3356b3b5b7
March 29, 2018
2
July 25, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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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

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
6307734409
paulgropi@aol.com
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