DEVICE: Bond -A-Braid (D798BAB2SAM0)

Device Identifier (DI) Information

Bond -A-Braid
BAB2SAM
In Commercial Distribution
BAB2SAM
RELIANCE ORTHODONTIC PRODUCTS INC
D798BAB2SAM0
HIBCC

1
113170088 *Terms of Use
Indications for Use: Bond-a-Braid is intended for use as a lingual retainer wire for retaining tooth position after orthodontic treatment. This is a single strand for sample evaluation
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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
Orthodontic retainer A dental orthodontic appliance, fixed or removable, used to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.
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FDA Product Code

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Product Code Product Code Name
DZC Wire, Orthodontic
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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

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Size Type Text
No Device Sizes
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Device Record Status

a174abcc-63dc-462c-8816-87360901440e
March 29, 2018
2
October 18, 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)

[?]
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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