Biocompatibility Testing for Medical Devices | Safe & FDA-Cleared Snore Solution

Biocompatibility testing for medical devices is essential to ensure that the device or material is safe for use in the human body, minimizing the risk of harm or adverse reactions. This testing is a critical component of comprehensive risk management, designed to protect users and ensure safety.

The Good Morning Snore Solution® (GMSS®) Mouthpiece has undergone rigorous third-party biocompatibility testing in compliance with international standards, including ISO 10993. These evaluations verify that the GMSS® Mouthpiece meets all safety criteria for medical devices. Based on thorough biocompatibility testing, clinical evaluation, and regulatory review, the GMSS® Mouthpiece received FDA clearance.

Manufactured from a proprietary plastic resin, the GMSS® Mouthpiece is designed with safety in mind. While the exact resin composition remains proprietary, it has been extensively tested by our supplier. The resin contains no hazardous ingredients and is not classified as harmful to health or the environment under OSHA Hazard Communication Standards (29 CFR 1910.1200).

The resin in not manufactured with any of the following substances: 

• Silicone

• Latex, CAS No. 9006-04-6

• Bisphenol A (BPA), CAS No. 80-05-7

• Butylated hydroxy anisole (BHA), CAS No. 25013-16-5

While these substances weren't intentionally added during the resin's mixing phase, we can't guarantee their complete absence. Trace amounts might be present in the raw materials or introduced during manufacturing, as our contract manufacturing facility produces other medical devices.

If you have a known allergy to any of these substances, we recommend discussing this with your doctor before using the Good Morning Snore Solution device.

 FDA 510(k) 193239