Is Your Night Guard Really Made in the USA? (And Why It Matters for Safety)

July 30, 2025 · Ashely Notarmaso

How Some “Made in USA” Night Guards Are Actually Outsourced

When you buy a custom night guard online, you expect it to be safe, high-quality, and made in the USA. But the truth is, many companies ship your dental scan overseas, where guards are manufactured with unknown materials and little oversight. This raises serious safety concerns, from BPA and latex exposure to poor durability.

At Sentinel Mouthguards, we believe transparency matters. That’s why every guard we make is crafted start-to-finish in our FDA-registered Florida lab using trusted, medical-grade plastics.

👉 This article is part of our [Complete Guide to Night Guard Safety], where we cover materials, allergens, and what makes a night guard truly safe.

The Risks of Overseas Night Guards

What actually happens with many online night guard companies is this:

1. They send you an impression kit from a U.S. facility (giving the appearance of a U.S.-based operation).

2. Once they receive your completed impression, they scan it digitally and create a 3D file (.STL format).

3. That file is then sent to a manufacturer in China, where the night guard is fabricated using low-cost labor and materials.

4. The finished guard is shipped back from overseas—sometimes with long wait times and no real way to ensure quality or safety standards. Overseas labs often mean weeks-long waits for replacements, leaving your teeth unprotected in the meantime.

5. Meanwhile, customers believe they’re receiving a guard "made in the USA."

And when overseas factories are involved, it becomes even harder to know whether the materials are truly safe. For a full breakdown of what makes a night guard safe (and what to watch out for), see our guide: Are Night Guards Safe?

💚 Want peace of mind that your guard is truly safe? Every Sentinel guard is made start-to-finish in our FDA-registered Florida lab using trusted U.S. and German materials. [Shop Now]

Why Manufacturing Location Matters for Safety

• Lack of Oversight: Once your scan is sent overseas, there’s no telling what materials are used, how they’re handled, or under what conditions your mouthguard is made.

• No FDA Compliance Guarantee: Many foreign manufacturers do not follow U.S. FDA requirements for medical devices.

• Risk of Allergens or Toxins: Without transparency, there's no way to verify if the materials used are BPA-free, latex-free, or safe for long-term oral use. Unknown materials may contain BPA, phthalates, or latex — potential allergens or toxins.

• Delayed Service & Support: If there's an issue with your guard, good luck getting quick adjustments or help.

Why Sentinel Mouthguards Is Different

At Sentinel Mouthguards, we believe that transparency, safety, and quality should never be outsourced.

✅ Made 100% in the USA
From start to finish, your night guard is fabricated at our Florida-based lab. We never send files overseas. Your dental impression is scanned, designed, and 3D-printed or handcrafted right here by our experienced team.

✅ Strict Material Safety Standards
We use only premium, FDA-approved materials sourced from the U.S. and Germany—never unknown foreign substitutes.

✅ Fast Turnaround & Real Customer Support
Our lab operates quickly (3–4 business days for production), and we offer direct support from real people who care. No overseas delays. No foreign call centers.

✅ Thousands of Happy Customers Since 2012
We’ve been protecting smiles for over a decade. Our reputation is built on honesty, craftsmanship, and care—not shortcuts.

Ask Before You Buy

Before you trust your health to just any online night guard company, ask these important questions:

• Where is the actual fabrication of the guard taking place?

• Are the materials safe for oral use?

• Can you speak with a real person if there’s a problem?

• Do they stand behind their product?

Frequently Asked Questions

How can I tell if my night guard was made overseas?
Check the fine print. If the company doesn’t clearly state “fabricated in the USA,” it’s often outsourced. Red flags include vague wording like “designed in the USA” or long shipping times. Some companies scan your impression here but manufacture the guard overseas.

Are overseas night guards less safe?
Often, yes. When guards are made overseas, there’s no guarantee they meet U.S. FDA standards. Materials may contain BPA, phthalates, or latex, and quality control is harder to verify. Custom U.S.-made guards, like those from Sentinel, use medical-grade plastics with full transparency.

Why does FDA registration matter for night guards?
FDA registration ensures a dental lab follows U.S. safety requirements for medical devices. This means the materials are tested for biocompatibility, the lab follows strict manufacturing standards, and the guards are safe for long-term oral use. Without FDA oversight, safety isn’t guaranteed.

Support a U.S.-Based Lab You Can Trust

At Sentinel Mouthguards, we’ve invested in the latest 3D-printing technology, advanced scanning, and industry-leading materials to bring you a better, safer night guard—without cutting corners.

🦷 Custom Night Guard Comparison:

Sentinel Mouthguards vs. China-Made Alternatives

🛡️ We don’t ship your smile overseas. We protect it right here at home.

💚 Your health shouldn’t be outsourced. Choose a night guard made with verified safe materials, crafted right here in the USA. Order your Sentinel custom night guard today.