Layer concept
- Soft exterior layer — currently positioned for adaptability and comfort.
- Structural layer — supports shape and functional response.
- Soft exterior layer — completes the tri-layer construction shown in the current material diagram.
Current application imagery
The existing site shows examples such as splints, sports mouth guards and other dental appliances. Applications should follow the official intended-use statement and current product documentation.
Thermoforming
VAMSA guidance recommends following package instructions, running trials when first using the material and adjusting heating time for the specific thermoformer. Processing guidance should use machine-specific settings only from the approved IFU.
Technical documentation
- sheet dimensions and thicknesses
- material/layer construction
- forming temperature/window
- recommended thermoformer settings
- trimming/finishing guidance
- storage and shelf life
- cleaning/care information
- intended use / contraindications if applicable
- biocompatibility and regulatory documents
- MSDS/SDS

