Is SomnoDent FDA approved? FDA 510(k) Clearances Checked

Short answer: SomnoMed (SomnoDent) has 11 FDA 510(k) clearances on record, not an FDA approval. The most recent is K261366 ("Virtus"), decided June 12, 2026 for Somnomed, Inc. (Plano, TX). The earliest in this list is K050592, decided July 12, 2005.

Product codes: LRK (Device, Anti-Snoring, Class II, 21 CFR 872.5570), PLC (Sleep Appliances With Patient Monitoring, Class II, 21 CFR 872.5570)
Applicants as filed: Somnomed, Inc.; Somnomed, Ltd.
FDA decision on every record listed: Substantially Equivalent (cleared)

SomnoMed (SomnoDent) 510(k) records

FDA 510(k) records for SomnoMed (SomnoDent)
510(k) number	Device name (as filed)	Applicant	Decision date	Product code	Decision
K261366	Virtus	Somnomed, Inc.Plano, TX	June 12, 2026	LRK	Substantially Equivalent
K233497	Rest Assure System	Somnomed, Inc.Plano, TX	October 3, 2024	PLC	Substantially Equivalent
K183443	SomnoDent Avant	Somnomed, Inc.Plano, TX	May 8, 2019	LRK	Substantially Equivalent
K162306	SomnoDent ALPHA	Somnomed, Inc.Frisco, TX	September 20, 2016	LRK	Substantially Equivalent
K150369	SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder	Somnomed, Inc.Frisco, TX	June 18, 2015	PLC	Substantially Equivalent
K140278	SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX	Somnomed, Inc.Frisco, TX	June 20, 2014	LRK	Substantially Equivalent
K130558	SOMNODENT HERBST; CLASSIC, FLEX	Somnomed, Inc.Frisco, TX	May 17, 2013	LRK	Substantially Equivalent
K121340	SOMNODENT G2	Somnomed, Inc.Frisco, TX	May 30, 2012	LRK	Substantially Equivalent
K102521	PANTINO PRO POSITINER	Somnomed, Inc.Denton, TX	March 28, 2011	LRK	Substantially Equivalent
K073004	SOMNOMED BFLEX	Somnomed, Inc.Denton, TX	January 30, 2008	LRK	Substantially Equivalent
K050592	SOMNOMED MAS RXA	Somnomed, Ltd.Stillwater, MN	July 12, 2005	LRK	Substantially Equivalent

Each 510(k) number links to FDA's own record, where you can read the summary or statement and the intended use. We grouped these records under SomnoMed (SomnoDent) by device and applicant name; if a product you are looking at is sold under a different name, search the lookup or FDA's database directly.

Is SomnoMed (SomnoDent) "FDA approved"?

Not in FDA's sense of the word. Anti-snoring and jaw-repositioning mouthpieces are Class II devices that reach the market through a 510(k) premarket notification. FDA "clears" a 510(k) when it finds the device substantially equivalent to one already legally sold. "Approval" is a different process (premarket approval, or PMA) used mainly for higher-risk Class III devices. So the accurate phrase for SomnoMed (SomnoDent) is "FDA cleared", for the specific models and dates in the table above.

What this page is, and what it is not

This is a copy of public FDA records, not a review. 40 Winks has not tested these devices for this page.
A 510(k) clearance means FDA found a device substantially equivalent to a device already legally on the market. It is not an FDA approval, it is not an endorsement by FDA or by 40 Winks, and it does not show that a device will work for you. FDA's own rule (21 CFR 807.97) says a 510(k) clearance does not mean FDA has approved the device.
A clearance covers the specific device and model in the filing. Check that the product you are buying matches the 510(k) number and name, and read the intended use in FDA's record.
Loud, regular snoring can be a sign of obstructive sleep apnea. Talk to a doctor or a dentist trained in sleep medicine before relying on a mouthpiece, and ask whether a sleep test makes sense.

How to check a clearance yourself

Open FDA's 510(k) Premarket Notification database.
Search by the 510(k) number (it starts with K) or by the device or company name.
Open the record and read the device name, applicant, decision date and the linked summary or statement, which describes the intended use.
If a seller says "FDA approved" or "FDA cleared" but gives no 510(k) number, ask for it.

Other sleep devices in this lookup

Search all 254 sleep-appliance records in the FDA clearance lookup, or browse by product code: Anti-Snoring Devices (LRK), Jaw Repositioning Devices (LQZ), Sleep Appliances With Patient Monitoring (PLC).