DEVICE: Prosthesis, Hawley Retainer, Palatal Expander, Spacer, Herbst, Nance HoldingArch (06970617030100)
Device Identifier (DI) Information
Prosthesis, Hawley Retainer, Palatal Expander, Spacer, Herbst, Nance HoldingArch
Not Applicable
In Commercial Distribution
SHENZHEN MINGHAO DENTURES CO., LTD.
Not Applicable
In Commercial Distribution
SHENZHEN MINGHAO DENTURES CO., LTD.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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Yes | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
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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. |
FDA Product Code
[?]Product Code | Product Code Name |
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NSR | Prosthesis, Orthodontic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
116a7fdd-f13b-42be-8604-f4d93126a520
March 29, 2018
2
September 14, 2016
March 29, 2018
2
September 14, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined