702 devices · GMDN 31863
A margin finishing dental file/rasp is a hand-held manual instrument used by dental professionals to smooth and shape tooth surfaces, bone structures such as alveolar bone, or dental restorations like fillings. It features fine ridged cutting surfaces at one or both working ends and is commonly designed as a one-piece, double-ended tool with a central handle, made from metals such as stainless steel or titanium.
As a reusable device, it is intended for multiple uses after proper cleaning and sterilization between patients. Regulatory oversight applies based on its classification as a non-powered, manual dental instrument, with requirements focused on material safety, design validation, and reprocessing instructions for reuse.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.