Almost every snoring mouthpiece sold online says it is “FDA cleared”, and some say “FDA approved”. We wanted to know what those words really mean, and whether they are true. So we went through the FDA’s own records: all 242 clearances for anti-snoring mouthpieces and jaw devices, from 1987 to August 2026, and the paperwork behind 31 mouthpieces you can buy online.
In this article
The short answer
- “FDA cleared” is not “FDA approved”. All 242 records are 510(k) clearances. None is an approval.
- Of the 31 consumer mouthpieces we checked, 20 are cleared for sale without a prescription, 8 only with a prescription, and 3 for both.
- Every clearance that mentions sleep apnea was for prescription use. A mouthpiece you can buy over the counter is cleared to reduce snoring, not to treat sleep apnea.
- A clearance belongs to one version of a product. Good Morning Snore Solution and VitalSleep were first cleared for prescription use, and got over-the-counter clearances only in 2020 and 2021.
- You can check any mouthpiece yourself in a few minutes. The steps are below.
What “FDA cleared” means, and what it doesn’t
Anti-snoring mouthpieces are Class II medical devices under the FDA rule for “intraoral devices for snoring and obstructive sleep apnea” (21 CFR 872.5570). Most reach the market through a 510(k): the maker shows the FDA that its device is “substantially equivalent” to one that is already legally sold. If the FDA agrees, the device is cleared.
That is a lower bar than approval, which is the process for higher-risk devices and needs clinical evidence that the device is safe and effective. A 510(k) clearance means the FDA accepted the comparison. It does not mean the FDA tested the mouthpiece, and it does not prove the mouthpiece will stop your snoring.
So when a website says a snoring mouthpiece is “FDA approved”, that is not accurate. In the FDA’s own database, every one of these devices is listed with the decision “Substantially Equivalent”.
What 242 FDA records show
We downloaded every 510(k) record under the FDA’s two product codes for these devices: LRK (“anti-snoring device”, 215 records) and LQZ (“jaw repositioning device”, 27 records). The oldest is from 1987, and the newest in the data is from 27 August 2026.
Clearances have become much more common. There were 79 in the 23 years from 1987 to 2009, and 163 since 2010:
Source: FDA 510(k) database, product codes LRK and LQZ, downloaded 21 October 2026
Most of the 242 records are from US companies (203), and many are for custom appliances that dental labs make from a mould of your teeth, such as Herbst-style and TAP appliances. These are sold through dentists, not online.
The 31 consumer mouthpieces we checked
We picked the mouthpieces in the records that are sold directly to the public, often as “boil and bite” or one-size devices. For each one we opened the FDA paperwork and read the “Indications for Use” (what the device is cleared to do) and the “Type of Use” (prescription, over the counter, or both).
| Mouthpiece (as named in the FDA record) | FDA number | Year | Type of use | Cleared for |
|---|---|---|---|---|
| ApneaRx Pro | K223901 | 2023 | Prescription | Snoring and mild to moderate sleep apnea |
| AVEOtsd tongue stabilizing device | K231663 | 2023 | Over the counter | Snoring |
| Difiney Advanced Anti Snoring Device 4.0 | K253355 | 2025 | Over the counter | Snoring |
| Dormiva Anti-Snoring Mouth Guard | K261134 | 2026 | Over the counter | Snoring |
| MPowRx Snoring Solution (Good Morning Snore Solution) | K081965 | 2008 | Prescription | Snoring |
| MPowRx Snoring Solution (Good Morning Snore Solution) | K193239 | 2020 | Over the counter | Snoring |
| Hushd Avera | K252161 | 2025 | Over the counter | Snoring |
| Hushd Pro Z-Link | K251784 | 2025 | Prescription | Snoring and mild to moderate sleep apnea |
| Morpheus | K210636 | 2022 | Prescription | Snoring or mild to moderate sleep apnea |
| Myosa and Myosa for Snorers | K252531 | 2026 | Both | Over the counter for snoring; prescription for sleep apnea |
| Oscimed Anti-Snore Mouth Guard+ | K231138 | 2024 | Over the counter | Snoring |
| PureSleep (OTC use) | K190058 | 2019 | Over the counter* | Snoring |
| QuietLab Pro | K253868 | 2025 | Over the counter | Snoring |
| SilentZPro 2.0 | K220688 | 2022 | Over the counter | Snoring |
| SleepRight Snore Aid | K250122 | 2025 | Both | Over the counter for snoring; prescription for sleep apnea |
| SleepTight Mouthpiece STZ | K191618 | 2019 | Over the counter | Snoring |
| SmartGuard Anti-Snoring Device | K200657 | 2021 | Over the counter | Snoring |
| Snorbliss Anti-Snoring Device | K261251 | 2026 | Over the counter | Snoring |
| Snore Bandit | K210910 | 2021 | Over the counter | Snoring |
| Snore Guard Advance | K102118 | 2010 | Prescription | Snoring and mild to moderate sleep apnea |
| SnØreNegatØr | K261912 | 2026 | Both | Over the counter for snoring; prescription for sleep apnea |
| SNOR LOCK | K222475 | 2022 | Over the counter | Snoring |
| SnoreRx | K170825 | 2017 | Over the counter | Snoring |
| Somnofit (see our Somnofit-S review) | K060795 | 2006 | Prescription | Snoring and mild to moderate sleep apnea |
| Somnos Anti-Snoring Mouth Guard | K201484 | 2020 | Over the counter | Snoring |
| Soundly Anti Snoring Device | K220330 | 2022 | Prescription | Snoring and mild to moderate sleep apnea |
| Vital Sleep | K092942 | 2010 | Prescription | Snoring |
| Vital Sleep | K201719 | 2021 | Over the counter | Snoring |
| ZQuiet | K180124 | 2018 | Over the counter | Snoring |
| ZQuiet Advance | K213088 | 2022 | Over the counter | Snoring |
| Zyppah Anti-Snoring Device | K182312 | 2019 | Over the counter | Snoring |
* The PureSleep paperwork could not be opened as a normal document, so this row uses the device name in the FDA record, “PureSleep (OTC use)”. “Snoring” means the record says the device is an aid to reduce snoring, usually in adults aged 18 or over. The table counts records, not brands: Good Morning Snore Solution and VitalSleep each appear twice.
Three things the records make clear
1. Sleep apnea claims come with a prescription
Nine records in our table mention sleep apnea: ApneaRx Pro, Hushd Pro Z-Link, Morpheus, Soundly, Snore Guard Advance, Somnofit (2006), SleepRight, Myosa and SnØreNegatØr. In every one, the sleep apnea use is for prescription only. SleepRight, Myosa and SnØreNegatØr also have an over-the-counter use, and in each case the paperwork limits that part to snoring alone.
This matters because loud snoring is a common sign of obstructive sleep apnea. The American Academy of Sleep Medicine and the American Academy of Dental Sleep Medicine advise that people with sleep apnea who use a mouthpiece get a custom, adjustable one from a qualified dentist, after a doctor’s diagnosis, rather than a non-custom device.
2. Over-the-counter clearance is fairly new
The older clearances in our table were all for prescription use: Somnofit in 2006, Good Morning Snore Solution in 2008, and VitalSleep and Snore Guard Advance in 2010. The oldest over-the-counter clearance in the table is SnoreRx in 2017. ZQuiet’s 2018 summary names that SnoreRx clearance as the over-the-counter device it was compared with.
3. A clearance covers one version of a product
Good Morning Snore Solution was cleared for prescription use in 2008 and for over-the-counter use in 2020. VitalSleep was cleared for prescription use in 2010. Its 2021 summary describes the newer device as identical except for its resins, and asks for “a change from prescription to over-the-counter (OTC) use” to “align with current products in commercialization”.
Somnofit shows why names matter. The 2006 record for “Somnofit” is for prescription use, and the same maker, Oscimed, has a 2024 over-the-counter record for an “Anti-Snore Mouth Guard+”. The FDA records do not use the name Somnofit-S, the version sold today, so they cannot tell you which record covers it. Our Somnofit-S review explains what the maker says.
How to check a mouthpiece yourself
- Find the FDA number. It starts with K and has six digits, such as K193239. Look on the box, the instructions or the maker’s website. If you can’t find one, ask the seller.
- Look it up. Search the number in the FDA’s 510(k) database. You can also search by device name or by product code LRK.
- Open the summary. On the record page, open the “Summary” or “Statement” document and find “Indications for Use” and “Type of Use”.
- Check the name and the use. Make sure the name matches the product you are buying, and that the use matches what the seller claims.
Be careful if a seller says “FDA approved”, says an over-the-counter mouthpiece treats sleep apnea, or can’t give you an FDA number.
Which over-the-counter mouthpiece suits your snoring?
A clearance tells you a mouthpiece may be sold to reduce snoring. It does not tell you which kind will help you, because that depends on why you snore. The mouthpieces sold over the counter work in one of two ways:
- Tongue devices hold the tip of your tongue forward with gentle suction. Nothing grips your teeth and your jaw stays where it is, so they suit people whose tongue falls back, people with jaw pain and people with dentures. Good Morning Snore Solution is one (over-the-counter clearance K193239, 2020). Read our Good Morning Snore Solution review.
- Jaw mouthpieces clip onto your teeth and hold your lower jaw slightly forward, which also pulls the tongue forward. They need healthy teeth and a comfortable jaw. VitalSleep adjusts in small steps (over-the-counter clearance K201719, 2021); read our VitalSleep review. We also reviewed Somnofit-S.
Not sure which kind you need?
Our free snore quiz finds your snore type in about a minute with four simple checks, and shows the device that matches.
Take the snore quiz →When to see a doctor
See a doctor before you buy a mouthpiece if someone has noticed that your breathing stops and starts in your sleep, if you wake up gasping, or if you feel very sleepy in the day. These are signs of sleep apnea, which needs a diagnosis. Over-the-counter mouthpieces are cleared for snoring only. Also talk to a dentist first if you have jaw pain, loose teeth, gum disease or dentures.
How we did this
We downloaded every record with product code LRK or LQZ from the FDA’s openFDA 510(k) database on 21 October 2026 (242 records, decisions from 1987 to 27 August 2026). From these we chose the 31 records for mouthpieces sold directly to the public. For each, we read the FDA paperwork: the “Type of Use” box on the Indications for Use form, or, where the summary states it in words, that statement. The counts by year include all 242 records.
What this does not show: the FDA records don’t say whether a product on sale today is the exact version that was cleared, and a clearance is not proof that a device works. We did not test any of these mouthpieces. For what the research says about how well they work, read do snoring mouthpieces work?
Using this data: journalists, bloggers and researchers are welcome to use these numbers. Please link to this page as the source. If you find a mistake, tell us through our contact page and we will correct it.
What to read next
- Not sure what kind of snorer you are? Take the free snore quiz. A mouthpiece only helps some types of snoring.
- Do snoring mouthpieces work? Who they help and who they don’t
- TMJ and snoring: what to try if your jaw hurts
Frequently Asked Questions
Is “FDA cleared” the same as “FDA approved”?
No. A cleared device was shown to be similar to one already on the market. An approved device went through a stricter review with clinical evidence. Anti-snoring mouthpieces are cleared, not approved.
Can I buy an FDA-cleared mouthpiece without a prescription?
Only if its clearance includes over-the-counter use. Of the 31 consumer mouthpieces we checked, 23 records include over-the-counter use. The FDA paperwork shows which type applies.
Does an FDA-cleared mouthpiece treat sleep apnea?
Not if you buy it over the counter. In every record we checked, sleep apnea use was for prescription only, after a diagnosis.
Does FDA clearance mean a mouthpiece works?
No. Clearance is about being similar to a device already sold. Whether a mouthpiece helps you depends on why you snore.
Sources
- U.S. Food and Drug Administration. openFDA device 510(k) data, product codes LRK and LQZ, downloaded 21 October 2026.
- U.S. Food and Drug Administration. 510(k) Premarket Notification database, records listed in the table.
- U.S. Food and Drug Administration. Product classification: LRK, anti-snoring device.
- Code of Federal Regulations. 21 CFR 872.5570, intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
- Ramar K, et al. Clinical practice guideline for the treatment of obstructive sleep apnea and snoring with oral appliance therapy: an update for 2015. J Clin Sleep Med, 2015.
This article is general information, not medical advice. See our medical disclaimer.
