DEVICE: The Panthera Anti-Snoring Device (07540204000015)

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Device Identifier (DI) Information

The Panthera Anti-Snoring Device
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Panthera Dental Inc
07540204000015
GS1
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The Panthera Anti-Snoring Device is a removable intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two custom fabricated splints that fit separately over the upper and lower teeth and engage by means of adjustable rods. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient’s pharyngeal space, improving their ability to exchange air during sleep.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
Mandible-repositioning antisnoring orthosis A removable intraoral device designed to prevent snoring and/or obstructive sleep apnoea by repositioning the lower jaw (mandible), frequently in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. The device is typically made of soft and/or hard materials (e.g., plastics and metals); it may or may not be available [non-prescription] over-the-counter (OTC). A number of different fixed (non-adjustable) and adjustable types using several techniques are available. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
LRK Device, Anti-Snoring
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Sterilization

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Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 23, 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)

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No
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None
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Production Identifier(s) in UDI

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Customer Contact

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855-233-0388
info@pantheradental.com
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