Safety & compliance

Safe enough to sleep with. Here is how we know.

Snorbliss® spends eight hours a night in your mouth. So before it went on sale it went through the FDA and an independent laboratory. This page shows what was checked, in plain words, with the documents behind it.

FDA-cleared Class II medical device

A couple sleeping quietly, the man wearing the Snorbliss anti-snoring mouthpiece
FDA clearance

Cleared by the FDA. Here is what that means for you.

Before an anti-snoring mouthpiece can be sold in the United States as a medical device, the FDA has to review it. FDA decided that Snorbliss® is substantially equivalent to a device already legally on the market, and gave it a number: K261251.

That number is public. You can search for it on the FDA's own website and see the same record we show here.

The exact wording the FDA reviewed
Snorbliss® Anti-Snoring Device is intended to aid in the reduction of snoring.

FDA documentUnaltered

FDA clearance letter and 510(k) summary

  • Issued by: U.S. Food & Drug Administration
  • Ref: K261251
  • Date: June 11, 2026
  • Pages: 9

Preview not loading, or only the first page showing? Use the download button below to read the whole file.

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Independent lab testing

Tested for your mouth

An independent laboratory tested the finished mouthpiece, not just the raw plastic, against the standards used for medical devices that touch the inside of the mouth. Three tests, three passes.

  • It does not harm living cells

    Anything that could leach out of the material was tested on living cells. Nothing harmful came out, even at full strength.

    • Test summaryPassed

    It does not harm living cells

    • Issued by: Independent accredited laboratory
    • Pages: AllPagesDrop
    Snorbliss® Endeavor Commerce, LLC · Test summary
    • Prepared by: Independent accredited laboratory

    It does not harm living cells

    What was checked

    Whether anything that can leach out of the mouthpiece harms living cells.

    How

    • The finished device (EVA trays together with the polypropylene frame and straps) was soaked in cell-culture fluid for 72 hours at body temperature, at the surface-to-fluid ratio the standard requires.
    • That fluid was then applied to living cells at full strength and at 75%, 50% and 25% dilution, next to a clean control and a deliberately toxic control.
    • Cell survival was measured. Under ISO 10993-5, survival below 70% counts as cytotoxic.

    Result

    Strength of extract Cells surviving Pass line
    25% 95.2% 70% or more
    50% 88.7%
    75% 85.2%
    100%, undiluted 81.4%

    The toxic control behaved as expected (7% survival), which confirms the test itself was working. Conclusion: no cytotoxic potential.

    Results apply to the samples tested. Quote the report number when requesting the full document.

    Written by Snorbliss from the laboratory report, in our own words. The full report is available on request.

  • It does not irritate the inside of your mouth

    The lining of the mouth is more sensitive than skin. No irritation was found with either type of extract.

    • Test summaryPassed

    It does not irritate the inside of your mouth

    • Issued by: Independent accredited laboratory
    • Pages: AllPagesDrop
    Snorbliss® Endeavor Commerce, LLC · Test summary
    • Prepared by: Independent accredited laboratory

    It does not irritate the inside of your mouth

    What was checked

    Whether the mouthpiece irritates the soft tissue inside the mouth.

    How

    • Two extracts of the finished device were prepared, as the standard requires: one in salt water and one in sesame oil, so that both water-soluble and oil-soluble substances are covered.
    • Each extract was applied to oral mucosa tissue using the model specified in ISO 10993-23:2021, alongside untreated controls.
    • The tissue was examined by eye and under a microscope and scored for irritation.

    Result

    Extract Score difference against control Irritation index
    Salt water 0 0.34
    Sesame oil 0 0.34

    Conclusion: no irritation effect on oral mucosa tissue with either extract.

    Results apply to the samples tested. Quote the report number when requesting the full document.

    Written by Snorbliss from the laboratory report, in our own words. The full report is available on request.

  • It does not cause an allergic reaction

    Repeated contact with the material did not trigger sensitization.

    • Test summaryPassed

    It does not cause an allergic reaction

    • Issued by: Independent accredited laboratory
    • Pages: AllPagesDrop
    Snorbliss® Endeavor Commerce, LLC · Test summary
    • Prepared by: Independent accredited laboratory

    It does not cause an allergic reaction

    What was checked

    Whether repeated contact with the material can set off an allergic reaction.

    How

    • Two extracts of the finished device were prepared, one in salt water and one in sesame oil.
    • The guinea pig maximization test described in ISO 10993-10:2021 was used, with an induction phase followed by a challenge phase and matched control groups.
    • Skin was scored for redness and swelling 24 and 48 hours after the challenge.

    Result

    No redness or swelling was seen in any animal with either extract. Conclusion: no sensitization reaction.

    Results apply to the samples tested. Quote the report number when requesting the full document.

    Written by Snorbliss from the laboratory report, in our own words. The full report is available on request.
Trademark

The name on the box is ours, and that is on the public record

Snorbliss is a registered trademark, registered for one narrow thing: mouthpieces that stop snoring. The registration document is below, unedited.

The exact wording on the registration
Class 010: Therapeutic mouthpieces for the prevention of snoring.

  • What it means when you buy

    A Snorbliss® mouthpiece comes from us. If you find the name on a marketplace listing we do not run, it is a counterfeit, and the registration is what lets us have it taken down. If you are unsure about a seller, send us the link.

USPTO documentPublic record

USPTO trademark record for SNORBLISS

  • Issued by: United States Patent and Trademark Office
  • Ref: Reg. 8003052 · Serial 99066376
  • Date: October 28, 2025
  • Pages: 2

Preview not loading, or only the first page showing? Use the download button below to read the whole file.

Downloaded from the USPTO on September 11, 2026. The registration is held by Endeavor Commerce, LLC, the same company named on the FDA clearance.

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Design patent

This shape is ours

The name is trademarked. The mouthpiece has its own patent, and it covers the exact shape you get in the box.

It is granted, not pending. The number is right here if you want to look it up.

  • We drew it, not a factory catalogue

    The tray and the frame are our own design. The patent covers that exact shape.

  • Granted, not pending

    A lot of brands print patented when all they have is an application. Ours went through, and the number is above.

  • Copies get taken down

    If the same shape turns up cheaper somewhere else, it is a copy, and we can have it removed.

  • Check it in a minute

    Paste the number into the USPTO search. The drawings come up on their site, not ours.