DEVICE: Ortho FlexTech (D798OFT20)

Device Identifier (DI) Information

Ortho FlexTech
OFT2
In Commercial Distribution
OFT2
RELIANCE ORTHODONTIC PRODUCTS INC
D798OFT20
HIBCC

1
113170088 *Terms of Use
Intended for use as a Lingual Retainer Wire. Ortho Flex Tech® is best used for lower lingual 3 to 3 retainers and upper lingual 2 to 2 fixed retainers. This is 14karat White Gold
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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

[?]
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

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

11e7746b-e502-440e-ae63-d12de48a8419
March 29, 2018
2
August 06, 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

[?]
Yes
No
No
No
Yes CLOSE

Customer Contact

[?]
6307734009
paulgropi@aol.com
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