How To Select The Clinical Evaluation Method For Magnetic Attachment?


Magnetic attachments are generally composed of female and male parts, and are divided into keyway type, bar type, snap type and ball-cap type according to the structural composition. If the product is indicated for the auxiliary retention of such restorations as removable partial denture and overlay denture, this product belongs to products listed in the “Catalogue of Medical Devices Exempted from Clinical Trials” (hereinafter referred to as the Catalogue), and clinical evaluation should be performed according to the clinical evaluation requirements for products listed in the Catalogue; if the product is used in combination with the implant to assist the retention of abutment and implant as well as the protection for implant prior to the placement of upper structure after implantation, this product should be considered as the upper restoration structure of implant and does not belong to products listed in the Catalogue. In this case, it is feasible to perform analysis and evaluation based on the data obtained in the clinical trial or clinical use of the predicate device or perform clinical evaluation through clinical trial.