In the pulp and dentin usage test, the material is filled in the prepared tooth cavity of the animal. After a certain period of time, the pulp and dentin is observed for histopathologic response to evaluate the irritation of the material to the pulp-dentine complex. Generally, dental pulp irritation may occur in all usages where whole enamel and/or partial dentin are removed. Therefore, for dental materials used in such case, the pulp and dentin irritation should be taken into consideration in biological evaluation.
For the adhesive and cement products, if the administrative counterpart regulates the product operation in the IFU, clearly requiring that “The product cannot be directly used to exposed pulp, and appropriate pulp protection measures should be used when necessary”, and clinicians can effectively reduce the risks of pulp and dentin irritation reaction of such products by following the operation norms, such products may be exempted from pulp and dentin usage test.
