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Somnofit-S Anti-Snore Mouthguard+

SNORELESSNOW LLC · Model S03/02 · UDI-DI 00860010528174

LRK

510(k) clearances

2,966

Adverse events (1 deaths)

Recalls

108

Facilities

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.

Recalls

Date	Firm	Reason
2026-04-27	Prismatik Dentalcraft, Inc.	Due to device not having FDA Clearance
2025-10-09	Myofunctional Research Company USA	Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
2022-05-23	Dental Choice Holding Llc	The device was marketed and sold in the US without FDA clearance.
2017-09-01	Respire Medical	Potential for device breakage during use
2017-09-01	Respire Medical	Potential for device breakage during use
2017-09-01	Respire Medical	Potential for device breakage during use
2017-09-01	Respire Medical	Potential for device breakage during use
2017-09-01	Respire Medical	Potential for device breakage during use
2009-07-27	Medtronic Xomed, Inc.	Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed
2009-07-27	Medtronic Xomed, Inc.	Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently place

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.