Translational Pathways for Smart and Bioactive Dental Biomaterials: Biocompatibility Standards, Sterilisation, Sustainability and Regulation

Smart and bioactive dental biomaterials aim to deliver functional and therapeutic effects in the oral cavity; clinical uptake requires translation from laboratory performance to safe, durable and regulated use. This review synthesises translational requirements for advanced dental and craniofacial biomaterials, focusing on risk‐based biocompatibility planning and reporting aligned with ISO 10993 and dentistry‐specific ISO 7405. Oral constraints include long‐term exposure to saliva and the oral microbiota, cyclic loading and release of active species or degradation products. The review summarises design and evaluation priorities for antibacterial and bioactive implant interfaces, including microbiome‐aware assessment informed by metagenomic signatures of peri‐implant dysbiosis and clinically relevant endpoints beyond standard in vitro screens. Implementation constraints include validating low‐temperature sterilisation for thermolabile polymers, functional coatings and additively manufactured parts, and substantiating sustainability claims using life‐cycle assessment consistent with ISO 14040/14044 and explicit system boundaries. The review also outlines regulatory, standardisation and economic factors shaping claim credibility, combination‐product classification, evidence generation and post‐market learning, alongside ageing‐related host variability. These elements provide a practical roadmap for developing dental biomaterials that remain verifiable, safe and functional across the device life cycle.