VitalSleep Safety, Materials & FDA Clearance
Clear information about what VitalSleep is, how it is made, and when it may not be right for you.
Intended use
VitalSleep is an adjustable mandibular advancement device, also called a MAD, intended to reduce snoring in adults. It molds to your teeth at home and allows gradual lower-jaw adjustment to help you find a comfortable position.
Important: VitalSleep is intended to reduce snoring. It is not intended to diagnose, treat, cure, or prevent sleep apnea.
VitalSleep at a glance
| Device type | Adjustable mandibular advancement device (MAD) |
|---|---|
| Intended use | Reduction of snoring in adults |
| FDA status | FDA-cleared Class II medical device |
| 510(k) references | K092942 and K201719 |
| Adjustment range | 0–8 mm in 1 mm increments |
| Fit | Heat-molded to your teeth at home |
| Sizes | Men’s standard size and Women’s size, about 10% smaller |
| Made in | USA |
FDA clearance
VitalSleep is FDA-cleared as a Class II medical device for snoring reduction. Its FDA 510(k) clearance references are K092942 and K201719.
FDA clearance means the device was reviewed through the FDA’s 510(k) process for its intended use. It does not mean FDA approval. It also does not mean the device is intended to treat sleep apnea or another medical condition.
VitalSleep is available over the counter. No prescription or dental appointment is required to purchase it. If you have questions about sleep-related breathing or your oral health, speak with a qualified healthcare professional.
Materials and construction
VitalSleep is made in the USA from materials selected for oral use:
- Polypropylene outer body
- EVA liners that soften during fitting and mold to your teeth
- Nylon adjustment screws
VitalSleep is BPA-free, latex-free, and metal-free. It contains no silicone.
Fit and adjustment
For a secure fit, follow the fitting instructions included with VitalSleep. The device may be re-molded up to three times if you need a better impression.
After fitting, start with little or no advancement. If the fit feels comfortable but you still want to reduce snoring, adjust both sides equally in 1 mm increments. Test each setting before moving farther forward. More advancement is not always better.
For complete fitting and adjustment information, visit the VitalSleep product page.
Care and cleaning
Rinse VitalSleep with cool water after each use. Clean it gently and allow it to dry completely before storing it in its case.
For a deeper clean, use a denture-cleaning tablet as directed. You may also use a diluted mouthwash solution of one part Listerine to ten parts water for 30 to 60 minutes. Hydrogen peroxide may be used for no longer than five minutes.
Do not use hot water to clean a molded device. Heat can change the fit. Do not place it in a dishwasher or leave it in direct heat.
Important warnings
VitalSleep is designed for adults with snoring. It is not appropriate for everyone.
Do not use VitalSleep if you:
- Are under 18 years old
- Have been diagnosed with central sleep apnea, unless directed by a licensed healthcare professional
- Have a severe respiratory disorder or serious breathing difficulty, unless directed by a licensed healthcare professional
- Have loose teeth, advanced periodontal disease, or a dental implant placed within the past year
- Have TMJ or jaw-joint problems, unless a qualified healthcare professional advises you to use it
Use may cause temporary tooth pressure, extra saliva, jaw tenderness, or changes in how your teeth meet. Stop using VitalSleep and contact a healthcare professional if you experience persistent pain, significant bite changes, jaw locking, or another concerning symptom.
VitalSleep is not designed to withstand teeth-grinding forces. Grinding may shorten its lifespan.
Snoring is not the same as sleep apnea
VitalSleep is not a sleep apnea device and does not replace a medical evaluation.
Talk with a qualified healthcare professional before using an anti-snoring mouthpiece if you wake up gasping or choking, someone has noticed pauses in your breathing, you have severe daytime sleepiness, or you have concerns about sleep apnea.
Guarantee and support
VitalSleep includes a 60-night money-back guarantee, free size exchanges, and 12-month replacement coverage under the current policies. Visit the VitalSleep product page for current details and support.
Common questions
Is VitalSleep FDA-approved?
No. VitalSleep is FDA-cleared, not FDA-approved. It is a Class II device intended for snoring reduction.
Does VitalSleep treat sleep apnea?
No. VitalSleep is not intended to diagnose or treat sleep apnea.
What is VitalSleep made from?
VitalSleep uses a polypropylene body, EVA liners, and nylon adjustment screws. It is BPA-free, latex-free, metal-free, and contains no silicone.
How long does VitalSleep last?
With regular use and proper care, VitalSleep is designed to last up to one year. Replace it sooner if it is damaged, worn, or no longer fits securely.
