The First and Only Fully FDA‑Approved Custom Over-the-Counter Night Guard
From the Remi At-Home Impression Kit to your custom Remi Night Guard, every step of the Remi process is FDA-Approved for over-the-counter use. No other company can make that claim.
Get Your Custom Night GuardWhat Does FDA-Approved Mean for You?
FDA approval means that our entire solution — including the Remi At-Home Impression Kit — has been reviewed by the U.S. Food and Drug Administration for safety and effectiveness.
You are not just buying a night guard. You are choosing the only complete over-the-counter end-to-end solution that meets this standard. For something that goes in your mouth every night, that level of scrutiny matters.
What Makes Remi Different
While other night guards are available over-the-counter, no other company offers a fully FDA-Approved over-the-counter end-to-end solution.
| Feature |  |
Other Brands |
|---|---|---|
| Over-the-Counter Night Guard | ✓ | ✓ |
| FDA-Approved Remi At-Home Impression Kit | ✓ | ✕ |
| End-to-End FDA Approval | ✓ | ✕ |
How It Works
Getting your custom FDA-Approved night guard is simple. Four steps, all from home.
Order Your Kit
Your FDA-Approved Remi At-Home Impression Kit ships directly to your door.
Take Impressions
Follow our easy instructions to take your dental impressions at home.
Send Them Back
Mail your impressions to us with the prepaid return label.
Receive Your Guard
Your custom-fit, professional-grade night guard arrives at your door.
Remi is the first and only company to receive FDA 510(k) over-the-counter clearance for the entire night guard system — from the Remi At-Home Impression Kit to the finished custom Remi Night Guards. Other brands have clearance for the guard alone.
Why FDA Approval Matters
Rigorously Evaluated
Our products have undergone thorough FDA evaluation for safety and effectiveness. You can trust every component of our solution.
Safe for Home Use
Our Remi At-Home Impression Kit is the only one FDA-Approved for at-home, over-the-counter use. Professional results without the dentist visit.
Highest Standard
For something you put in your mouth every night, you deserve the highest regulatory standard. Remi is the only over-the-counter solution that delivers it.
Clinical Study
The Remi At-Home Impression Kit and Night Guard Clinical Study
At Remi, we take your dental health seriously — which is why we didn't just say our night guards fit great. We backed it up. We conducted a professional, double-blind clinical study comparing the quality of night guards made from the Remi At-Home Impression Kit versus those made from in-office dentist impressions.
The Results Speak for Themselves
of night guards were rated "Excellent Fit" by both physicians and participants. Zero guards received a poor rating. No adverse events were reported.
What This Study Was About
Millions of people struggle with teeth grinding, clenching, and bruxism. Custom night guards are a trusted solution — but traditional dentist-made impressions are costly and inconvenient. Remi's goal was to test whether our Remi At-Home Impression Kit could deliver the same high-quality fit without the in-office visit. This clinical trial evaluated how safe, effective, and precise our DIY impressions really are, using a scientifically sound and double-blind methodology.
How the Study Worked
- Double-Blind Testing: Neither the physician nor the patient knew which night guard came from a home impression or an in-office one. This eliminated bias.
- Process: Each person received two night guards, one made from a dentist-taken impression, one from the Remi At-Home Impression Kit.
- Assessment: Each guard was graded by both the physician and the participant on fit and performance, without knowing which was which.
Conclusion
The findings from our clinical trial confirm what more than 500,000 customers already know, Remi delivers dentist-quality night guards without the dentist's price tag or inconvenience. With a 98.33% excellent fit rate and no adverse events, the Remi At-Home Impression Kit is not only effective, but safe, comfortable, and reliable. When you choose Remi, you're not just getting a night guard, you're choosing clinically proven protection, made simple.
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