Dental devices and materials are evaluated most often as medical devices, though there are special needs to address. Some dental devices may have exposure to dentin, mucosal tissue, salivary enzymes, or foods. In other cases, the device is implanted and may be evaluated much like an orthopedic implant device. Typical products in this category include restorative materials (alloys, ceramics, polymers), prosthetic materials, UV curable materials, drug-release materials, and other bone- or soft-tissue-implant materials.
Standards and Regulation
Dental devices are evaluated against ISO 10993 for routine biological tests and according to vertical standards for any specialty tests required (ISO 7405). Test models can be found in the literature and in reference texts, such as Stanley, H., Toxicity Testing of Dental Materials.
NOTE: This list provides an overview of tests that should be considered for dental devices—our technical specialists and scientists will partner with you to develop specific, cost-effective test programs that minimize your time to market.