Identity
- Trade Name
- Somnofit-S Anti-Snore Mouthguard+ FDA UDI
- Generic Name
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
- Device Name
- The Somnofit-S Anti-Snore Mouthguard+ is a thermoforming mandibular advancement device to reduce snoring. The device works by pulling the lower jaw forward. The device combines an upper and lower molding with thermal impression material to conform to the user's teeth morphology with an adjustable mechanism to position the user’s lower jaw according to the user’s need. The Anti-Snore Mouthguard+ is a “Boil and Bite” device where both the upper and lower moldings are constructed out of moldable material when heated in a water bath with rigid frames that allow for the straps to be attached to adjust the fitting. The device additionally comes with a ventilated storage box and Instructions for Use. This ventilated storage box is only provided for storage when the device is not in use and does not impact intended use of the device. FDA UDI
- Model / Reference
- S03/02 FDA UDI
- Description
- The Somnofit-S Anti-Snore Mouthguard+ is a thermoforming mandibular advancement device to reduce snoring. The device works by pulling the lower jaw forward. The device combines an upper and lower molding with thermal impression material to conform to the user's teeth morphology with an adjustable mechanism to position the user’s lower jaw according to the user’s need. The Anti-Snore Mouthguard+ is a “Boil and Bite” device where both the upper and lower moldings are constructed out of moldable material when heated in a water bath with rigid frames that allow for the straps to be attached to adjust the fitting. The device additionally comes with a ventilated storage box and Instructions for Use. This ventilated storage box is only provided for storage when the device is not in use and does not impact intended use of the device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860010528174 FDA UDI
- 510(k) Number
- K231138 FDA UDI
- FDA Product Code
- LRK FDA UDI
- GMDN Term
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5570 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Category: Mandible-repositioning sleep-disordered breathing orthosis
Somnofit-S Anti-Snore Mouthguard+ by Snorelessnow Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Mandible-repositioning sleep-disordered breathing orthosis.
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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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Snorelessnow Llc
Sources (1)
- FDA UDI 0bd92209-3126-4b1e-9055-7f20f73caf5b 34 fields · synced May 30, 2026