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Dental devices and materials are most often evaluated as medical devices, though there are special needs to address. Some dental devices may have exposure to some or all of the following: dentin, mucosal tissue, oral enzymes or foods. In other cases, the device may be 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 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). Animal models can be found in the literature and in reference texts (e.g. Stanley, H., Toxicity Testing of Dental Materials).
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