DEVICE: A2 (D798AR1)

Device Identifier (DI) Information

A2
AR
In Commercial Distribution
AR
RELIANCE ORTHODONTIC PRODUCTS INC
D798AR1
HIBCC

5
113170088 *Terms of Use
The A2 Rectangular Attachment Form can be used for individual tooth movement. Qty 5
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Dental mould A hollow form in which a dental material is intended to be injected, cast, or pressed to produce a particular shape.
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FDA Product Code

[?]
Product Code Product Code Name
KXR Applicator, Resin
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FDA Premarket Submission

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

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Store at ambient conditions.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

cbd95831-a085-4792-85a5-5d3093b0e078
March 29, 2018
2
July 25, 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: D798AR0 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
6307734009
paulgropi@aol.com
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