Somnofit-S Anti-Snore Mouthguard+
Basic Information
- Brand Name
- Somnofit-S Anti-Snore Mouthguard+
- Primary DI
- 00860010528174
- Version / Model
- S03/02
- Company Name
- SNORELESSNOW LLC
- Labeler DUNS
- 125415441
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-12
- Public Version
- 2
- Public Version Date
- 2025-04-22
- Public Version Status
- Update
- Public Device Record Key
- 0bd92209-3126-4b1e-9055-7f20f73caf5b
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LRK | Device, Anti-Snoring | Dental | 872.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860010528174 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231138 | 000 |