Duns Number:203254607
Device Description: The Panthera Anti-Snoring X3 Device is a removable intraoral device used for treating snor 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.
Catalog Number
-
Brand Name
The Panthera Anti-Snoring X3 Device
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171576
Product Code
LRK
Product Code Name
Device, Anti-Snoring
Public Device Record Key
b87bc69d-6769-4244-8b68-a62ac3be7acc
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 10, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |