Biocompatibility & Safety
Everything you need to know to use your GMSS device safely, comfortably, and effectively.
Biocompatibility & Safety
The Good Morning Snore Solution mouthpiece is a clinically tested, FDA-cleared medical device designed with your safety and comfort in mind.
Biocompatibility Testing for Medical Devices
Biocompatibility testing is a critical safety evaluation process for medical devices that come into prolonged contact with the human body. For oral devices like the Good Morning Snore Solution mouthpiece, which is worn throughout the night, this testing ensures that materials do not cause adverse reactions, irritation, or toxicity. These rigorous assessments are conducted by independent laboratories following internationally recognized standards to verify that the device is safe for extended use in the oral cavity.
Safe & FDA-Cleared Snore Solution
The Good Morning Snore Solution mouthpiece has undergone comprehensive third-party biocompatibility testing in full compliance with ISO 10993, the international standard for biological evaluation of medical devices. This testing includes assessments for cytotoxicity, sensitization, and irritation. Following clinical evaluation and regulatory review, the device received FDA clearance, confirming its safety and effectiveness for treating snoring.
Why Biocompatibility Testing Matters
Biocompatibility testing minimizes the risk of adverse reactions such as tissue irritation, allergic responses, and potential toxicity from prolonged material contact. For a device worn in the mouth for 7-8 hours each night, these evaluations are essential to ensure long-term safety. The testing process examines how materials interact with oral tissues, saliva, and the body's immune system, providing confidence that the device will not cause harm during extended nightly use.
Certified Safe Materials
The Good Morning Snore Solution mouthpiece is manufactured using a proprietary plastic resin specifically engineered for medical applications. This medical-grade material complies with OSHA Hazard Communication Standards (29 CFR 1910.1200), ensuring transparency about material composition and safety. The resin has been carefully selected and tested to meet the stringent requirements for devices intended for prolonged oral contact.
Resin Safety Breakdown
The medical-grade resin used in the Good Morning Snore Solution mouthpiece does NOT contain the following substances:
- No Silicone
- No Latex
- No Bisphenol A (BPA)
- No Butylated Hydroxyanisole (BHA)
Known Allergens & Precautions
While the proprietary resin is specifically designed to avoid harmful substances and common allergens, trace amounts of certain materials may be present due to raw material composition or manufacturing processes. If you have known allergies or sensitivities to plastics or medical devices, we recommend consulting with your healthcare provider before using this product. Your doctor can help determine if the Good Morning Snore Solution mouthpiece is appropriate for your individual health needs.
