Somnofit-S Anti-Snore Mouthguard+

Primary DI
00860010528174
Brand
Somnofit-S Anti-Snore Mouthguard+
Company
SNORELESSNOW LLC
Model
S03/02
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.
Published
2025-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LRKDevice, Anti-Snoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRKDevice, Anti-SnoringDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231138000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231138000Aniti-Snore Mouthguard+Oscimed SA2024-01-16LRK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010528174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010528174008600105281748600105281740860010528174

GMDN Terms#

Term, Definition table
TermDefinition
Mandible-repositioning sleep-disordered breathing orthosisA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
125415441
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D8410491E1TAP 3 EliteOrtho Solutions, LCLRK2026-02-25
D8418053R1Respire Blue+ HardOrtho Solutions, LCLRK2026-02-25
D8418054R1Respire Blue+ Hard/SoftOrtho Solutions, LCLRK2026-02-25
D8418056R1Respire Blue+ EFOrtho Solutions, LCLRK2026-02-25
D8418260R1Respire Pink AT HardOrtho Solutions, LCLRK2026-02-25
D8418261R1Respire Pink AT Hard/SoftOrtho Solutions, LCLRK2026-02-25
D8418262R1Respire Pink AT Micro HardOrtho Solutions, LCLRK2026-02-25
D8418263R1Respire Pink AT Micro Hard/SoftOrtho Solutions, LCLRK2026-02-25
D8418265R1Respire Pink AT EFOrtho Solutions, LCLRK2026-02-25
D8418267R1Respire Pink AT Micro EFOrtho Solutions, LCLRK2026-02-25
00860015164407EMANew Image Dental Laboratory, Inc.LRK2026-02-11
00692121035513SleepRightSplintek Inc.LRK2025-12-17
07540204000275Panthera D-SAD Classic DuoPanthera Dentaire IncLRK2025-11-28
07540204000282Panthera D-SAD X3 DuoPanthera Dentaire IncLRK2025-11-28
00860002336596Itus MouthguardzShinrin-Yoku Traders LLCLRK2025-08-25
00860002336572Itus MouthguardzShinrin-Yoku Traders LLCLRK2025-05-01
00850072689005VitalSleepThe Snore Reliever Company, LLCLRK2025-04-09
00850072689012VitalSleepThe Snore Reliever Company, LLCLRK2025-04-09
DR3064993Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR4032584Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR5023119Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR5032714Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR5044538Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR5071026Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR6022107Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR6037018Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR6037022Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR6062580Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR7006994Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01
DR7050810Emerald HerbstIsland Dental Lab Inc. DBA Emerald Dental LabLRK2025-04-01