Case study
Makrolon® Polycarbonate Solves Bruxism Challenge
Asesso Health's G-Series Grind Guard is the only anatomically correct mouthguard purpose-built for bruxism and TMD. Its rigid splint, made from Covestro's Makrolon® 2458 polycarbonate, delivers the biocompatibility, stability, and molding performance needed for this connected-care device.
Bruxism, or chronic teeth grinding, affects millions and can cause jaw pain, headaches, and long-term dental damage. Most sufferers stop wearing their mouthguard because it is too bulky, uncomfortable, or does not stay in place. Guards made entirely of soft material can worsen the condition by triggering a chewing response. Asesso Health set out to engineer a better solution: an injection-molded, boil-and-press mouthguard with an anatomically correct fit and a rigid polycarbonate splint designed to resist bite force and deter grinding in moderate-to-severe cases.
We needed a medical-grade polycarbonate for the splint that could meet strict biocompatibility standards while performing reliably in a high-volume injection molding process. Covestro's Makrolon® 2458 polycarbonate gave us confidence that the splint would maintain its dimensional stability to stay securely on the user's teeth.
The boil-and-press fitting process, where the device is placed in boiling water and custom-shaped to the user's teeth, ruled out most medical-grade polymers, which warp, discolor, or degrade under repeated heat exposure. The splint material also had to meet biocompatibility requirements according to certain ISO 10993 tests, support high-volume injection molding, and provide comprehensive engineering documentation to satisfy the regulatory and supply chain requirements of a consumer healthcare product.
Covestro's Makrolon® 2458 polycarbonate met every requirement. It withstands repeated steam exposure at 121°C, preserving the dimensional accuracy needed for a secure, comfortable fit. Its biocompatibility per ISO 10993 and comprehensive engineering documentation gave Asesso Health the regulatory confidence for a high-volume consumer product. The result is the G-Series Grind Guard, a dual-material mouthguard paired with a sensor module and mobile app that enables users to monitor bruxism symptoms and track progress over time.
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Key benefits
- Biocompatible: Meets ISO 10993 requirements, supporting use in consumer healthcare devices.
- Thermally stable: Withstands repeated steam exposure at 121°C without warping or dimensional loss.
- Process-ready: Optimized for high-volume injection molding with full engineering documentation.
- Bite-resistant: Rigid splint structure deters grinding behavior in moderate-to-severe bruxism.
- Connected-care ready: Compatible with sensor modules and digital health apps for data-driven outcomes.
FAQs
Makrolon® 2458 polycarbonate is a medical-grade polycarbonate biocompatible according to certain ISO 10993 test requirements. It offers a low viscosity for reliable injection molding, good release characteristics, and compatibility with EtO and steam sterilization at 121°C. These properties make it a trusted choice for consumer healthcare and medical device manufacturers.
The boil-and-press fitting process used to custom-shape the G-Series Grind Guard requires a polymer that withstands repeated exposure to boiling water without warping. Makrolon® 2458 polycarbonate maintains dimensional stability through steam exposure at 121°C, ensuring the splint retains its shape and continues to fit securely after the fitting process.
Yes. Makrolon® 2458 polycarbonate is specifically optimized for injection molding with a melt temperature range of 280 to 320°C and a mold temperature of 80°C. Its low viscosity and easy-release characteristics support consistent, high-volume production with minimal processing defects.
Covestro provides comprehensive engineering and regulatory documentation for Makrolon® 2458 polycarbonate, including biocompatibility data per ISO 10993 test requirements. This supports medical device manufacturers in meeting regulatory and supply chain requirements for consumer healthcare products.
Bruxism is a condition involving chronic, involuntary teeth grinding or jaw clenching, most often occurring during sleep. It can cause jaw pain, headaches, worn enamel, and Temporomandibular Joint Disorder (TMD). The G-Series Grind Guard by Asesso Health uses a rigid Makrolon® polycarbonate splint to resist bite force and deter grinding, paired with a sensor module and mobile app for symptom tracking and progress monitoring.
