Mucosal-Contact Photopolymer Devices: Saliva, Mechanical Cycling, Biofilm, Extractables and Use-State Qualification

Mucosal-contact photopolymer devices operate in a coupled chemical, mechanical and microbial environment. Saliva or other secretions wet and transport constituents; temperature and pH change over time; mastication, speech, insertion and removal impose cyclic load; finishing controls roughness and plaque retention; cleaning changes both chemistry and surface; and biofilm can alter local exposure and mechanical reliability. Qualification cannot be reduced to immersion in water, a dry flexural test or one cytotoxicity result. This review defines a use- state framework for oral and other mucosal-contact devices made by vat photopolymerisation. It freezes the final device-process configuration, maps direct and indirect contact, builds a secretion and thermal-cycle model, quantifies time-resolved release, couples fatigue and wear to surface and fit, and treats biofilm as an exposure modifier rather than a single microbial count. Evidence is integrated through non-compensatory gates for chemistry, mucosal response, mechanics, biofilm, hygiene and lifecycle stability. Published dental studies illustrate process-sensitive monomer release, saliva-ageing effects, microbial adhesion and biofilm-dependent strength variability, but their material-specific results are not generalised. The output is a traceable qualification plan without proprietary formulation or universal acceptance limits.

ER-256 · Version 0.4.