Identity
- Trade Name
- The Panthera Anti-Snoring X3 Device FDA UDI
- Generic Name
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 1 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540204000022 FDA UDI
- 510(k) Number
- K171576 FDA UDI
- GMDN Term
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Classification
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
The Panthera Anti-Snoring X3 Device by Panthera Dentaire Inc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K171576 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Panthera Dentaire Inc
Sources (1)
- FDA UDI b87bc69d-6769-4244-8b68-a62ac3be7acc 37 fields · synced May 30, 2026