The First and Only Fully FDA-Approved Custom Over-the-Counter Night Guard
Starting with the Remi At-Home Impression Kit and ending with your custom Remi Night Guard, each stage of the Remi process holds FDA approval for over-the-counter use. No other company can say the same.
Get Your Custom Night GuardWhat Does FDA-Approved Mean for You?
Being FDA-approved means the U.S. Food and Drug Administration has examined our whole solution, the Remi At-Home Impression Kit among it, for both safety and effectiveness.
What you are getting is more than a night guard. It is the one complete over-the-counter, start-to-finish solution held to this standard. When something sits in your mouth every night, that degree of scrutiny counts.
What Makes Remi Different
Although you can buy other night guards over-the-counter, no other company provides an over-the-counter solution that is FDA-Approved from beginning to end.
| Feature |
|
Other Brands |
|---|---|---|
| Over-the-Counter Night Guard | ✓ | ✓ |
| FDA-Approved Remi At-Home Impression Kit | ✓ | ✕ |
| End-to-End FDA Approval | ✓ | ✕ |
How It Works
Your custom FDA-Approved night guard is easy to get. It takes four steps, and you do them all at home.
Order Your Kit
Your FDA-Approved Remi At-Home Impression Kit is delivered straight to your door.
Take Impressions
Use our simple directions to take dental impressions at home.
Send Them Back
Send your impressions back to us using the prepaid return label.
Receive Your Guard
A professional-grade night guard, custom fitted to you, is delivered to your door.
Remi is the first and only company granted FDA 510(k) over-the-counter clearance for the complete night guard system, covering everything from the Remi At-Home Impression Kit through the finished custom Remi Night Guards. Competing brands are cleared only for the guard itself.
Why FDA Approval Matters
Rigorously Evaluated
The FDA has closely evaluated our products for safety and effectiveness. Every part of our solution can be trusted.
Safe for Home Use
Ours is the only impression kit with FDA approval for over-the-counter use at home. You get pro-level results and skip the dentist trip.
Highest Standard
Anything you place in your mouth every night merits the strictest regulatory bar. Remi is the one over-the-counter solution that meets it.
Clinical Study
The Remi At-Home Impression Kit and Night Guard Clinical Study
At Remi, we take your dental health seriously — so instead of merely claiming our night guards fit well, we proved it. We ran a professional double-blind clinical study that compared night guards made with the Remi At-Home Impression Kit against guards made from impressions taken at a dentist's office.
The Results Speak for Themselves
of the night guards earned an "Excellent Fit" rating from physicians and participants alike. Not one guard got a poor score. No adverse events were recorded.
What This Study Was About
Teeth grinding, clenching, and bruxism affect millions of people. Custom night guards are a dependable remedy, yet impressions from a dentist cost a lot and take time out of your day. Remi set out to learn whether the Remi At-Home Impression Kit could achieve an equally excellent fit with no office appointment. This clinical trial measured the safety, effectiveness, and accuracy of our DIY impressions through a scientifically rigorous double-blind design.
How the Study Worked
- Double-Blind Testing: Neither physicians nor patients were told whether a given night guard came from an at-home impression or one made in an office. That removed bias.
- Process: Every participant got a pair of night guards: one from an impression a dentist took, the other from the Remi At-Home Impression Kit.
- Assessment: Physicians and participants both rated each guard for fit and performance, with no knowledge of which guard was which.
Conclusion
Results from our clinical trial back up what over 500,000 customers have already found: Remi provides night guards at dentist-level quality, minus the dentist's cost and hassle. Thanks to a 98.33% excellent fit rate and zero adverse events, the Remi At-Home Impression Kit proves effective, safe, comfortable, and dependable. Choosing Remi means more than buying a night guard; it means selecting protection with clinical proof behind it, made easy.
FAQs
Ready to Try the Guard Clinically Proven to Fit?
Starting from
45-Night Perfect Fit Guarantee · Free Shipping