This document specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for an endosseous dental implant that may include:
— implant body,
— implant abutment,
— abutment screw,
— implant connecting part
— implant connecting part screw
— prosthetic screw,
— implant cover screw,
— transmucosal healing component.
This document includes requirements for intended use and performance, design attributes, components, biocompatibility, manufacturing, packaging, sterilization, shelf life, marking, labelling and information supplied by the manufacturer.
The following devices are not included within the scope of this document:
— Dental implant incorporating animal or human components or bioactive characteristics,
— Custom-made devices that have no pre-fabricated connection,
— Implantable materials for bone filling and augmentation in oral and maxillofacial surgery,
— Membrane materials for guided tissue regeneration in oral and maxillofacial surgery,
— Specific instruments indicated to be used as part of a dental implant system.
NOTE 1 ISO 22794 gives the necessary content of technical files for implantable materials for bone filling and augmentation in oral and maxillofacial surgery. ISO 22803 gives the necessary content of technical files for membrane materials for guided tissue regeneration in oral and maxillofacial surgery. These materials require a separate technical file.
NOTE 2 ISO 13504 gives the general requirements for specific instruments indicated to be used as part of a dental implant system. These instruments require a separate technical file.
NOTE 3 Custom made devices are defined in the following document IMDRF/PMD WG/N49 - Definitions for Personalized Medical Devices.
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