AccessGUDID - DEVICE: The Panthera Anti-Snoring X3 Device (07540204000022)

GUDID

Device Identifier (DI) Information

Brand Name: The Panthera Anti-Snoring X3 Device
Version or Model: 1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Panthera Dentaire Inc

Primary DI Number: 07540204000022
Issuing Agency: GS1
Commercial Distribution End Date: August 17, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 203254607 *Terms of Use

Device Description: The Panthera Anti-Snoring X3 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. 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47526	Mandible-repositioning sleep-disordered breathing orthosis	A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically 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. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171576	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b87bc69d-6769-4244-8b68-a62ac3be7acc
Public Version Date: July 01, 2024
Public Version Number: 4
DI Record Publish Date: May 10, 2018