Dental devices and antimicrobial resistance: challenges, innovations, and regulatory compliances.

Antimicrobial resistance (AMR) is an escalating threat to infection control in dentistry, where dense multispecies biofilms and frequent device-tissue contact can select for and disseminate antibiotic resistance genes (ARGs). The oral cavity functions as a reservoir and exchange network for ARGs (the oral resistome), enabling multidrug-resistant (MDR) infections and treatment failure, particularly on dental implants, restorative materials, and dental unit waterlines when reprocessing or maintenance is inadequate. Anti-biofilm surface engineering, including antimicrobial peptide-functionalized coatings, silver-based nanostructures, and nitric oxide-releasing platforms, offers non-antibiotic approaches to reduce adhesion and disrupt early biofilm development. However, translation requires addressing durability, long-term biocompatibility and toxicology (e.g., ion release), the potential for resistance or tolerance under sublethal exposure, and clinically meaningful validation in relevant multispecies models and human studies. Regulatory expectations (e.g., FDA quality system requirements under 21 CFR Part 820 and international standards ISO 13485, ISO 14971, and ISO 10993-1) frame risk management, antimicrobial performance claims, sterilization/reprocessing validation, and postmarket surveillance. Aligning antimicrobial stewardship with validated device design, sterilization, and monitoring strategies is essential to mitigate AMR proliferation and improve long-term clinical outcomes. This article is a comprehensive narrative review focusing on AMR in dental devices, materials innovation, and regulatory frameworks.