Is your Snoring Mouthpiece FDA Approved?

The United States Food and Drug Association, or FDA, is in charge of protecting public safety and health. In order to receive FDA approval, an item must go through certain processes to ensure its safety for public use.

If you are shopping for a snoring mouthpiece, be selective in the product you choose. A snoring mouthpiece that is FDA approved will guarantee the mouthpiece is safe.

Class Two Devices

The FDA has three classifications when it comes to devices class one, class two, and class three. Snoring mouthpieces are classified as class two devices. This means they have a slightly higher risk than class one but not as much risk as class three.

Class two devices require stricter regulation to ensure they are safe for public use. Additional items that fall under the class two device categories include powered wheelchairs, condoms, and pregnancy tests.

Why is FDA Approval Important?

The FDA requires that all snoring mouthpieces are made of medical grade plastic. This type of plastic is ideal for sensitive equipment which needs to endure frequent sterilization. Medical grade plastic is resistant to corrosion, temperature resistant and capable of withstanding large amounts of wear and tear.

They look at the shape, breathing capacity, and how secure the device is to ensure you are not at risk while sleeping.

Guaranteeing that your snoring mouthpiece is FDA approved also protects you from purchasing a mouthpiece which may contain toxins.

Considering you will sleep with your snoring mouthpiece every night it is important to keep these things in mind.

How to Tell if Your Snoring Mouthpiece is FDA Approved

Although this is against the law, some companies may label their products as FDA approved when in reality they are not. The FDA provides a database of all their approved devices. Before purchasing an item check the FDA established registration and device listing database to ensure the product is, in fact, FDA approved.

When searching for your mouthpiece on the database begin with typing in the brand name of the desired mouthpiece. If there are no results, then type in the manufacturer’s name. In the unfortunate case that the mouthpiece is still not listed email the snoring mouthpiece company and request the 10-digit FDA registration number.

Additional Safety Tips

As with any device always read the instructions thoroughly before use. Snoring mouthpieces may seem simple, but there are guidelines you must follow for your safety.

Tell your sleep specialist or doctor if you have any pre-existing conditions that may affect your suitability for a mouthpiece. If you have a history of dental issues speak with your dentist before purchasing a mouthpiece. Patients with loose teeth, for example, may be unsuitable candidates.

FDA Approved Snoring Mouthpieces

1. SnoreRx- Stop Snoring Mouthpiece

The design of the SnoreRx includes a large frontal breathing hole, is adjustable for the perfect fit, and is made of latex and BPA free medical grade plastic. The average lifespan is around 12 to 15 months.

The SnoreRx is the only device approved by the FDA for over-the-counter sales.

FDA Cleared Snoring Mouthpieces

FDA Cleared devices means these devices are cleared for sale online, but not over-the-counter in stores.   FDA Clearance means the product is safe but has not been thoroughly tested to sell without a prescription.

1. Zyppah

This clinically proven snoring mouthpiece is very comfortable for snorers with crowns, bridgework, and dentures. The Zyppah is also made of soft latex and BPA free medical grade plastic. The one size fits all no bite design ensures it will last you a long time.

2. TheraSnore Mouthpiece

The TheraSnore mouthpiece must be fitted by your dentist and will last you anywhere from 18-24 months. In the United States two versions are available, the original and the adjustable. The TheraSnore is fitted using the boil and bite method as well as adjusted using small increments that run along the side.

3. Good Morning Snore Solution Mouthpiece

This mouthpiece works well for tongue-based snorers. It is one size fits all, BPA and latex free, and can be worn by patients with crowns and bridgework, as long as they aren’t on the front teeth. It is not advised to wear this product with full dentures, but partial dentures are okay. Like the Zyppah the Good Morning Snore Solution Mouthpiece has a no bite design making it long lasting.

4. Sleep Tight Mouthpiece

Utilizing the boil and bite method to fit your mouth, the Sleep Tight Mouthpiece is a comfortable solution to your snoring problem. It also contains an air hole in the front, so you can breathe with ease.

5. VitalSleep Mouthpiece

The VitalSleep mouthpiece is made with BPA and Latex free thermoplastic. It comes in two sizes, regular and small, and is also fitted using small increments. Like SnoreRx and Sleep Tight mouthpieces the VitalSleep also has a breathing hole at its front.

Final Thoughts

The FDA approval guarantees you are purchasing a safe, reliable product. With different designs and features of anti snoring mouthpieces available it is best to consult your sleep specialist, doctor or dentist so they can help you choose the right fit.