This document specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for an endosseous dental implant that can include:

u000bu000bimplant body;u000bimplant abutment;u000babutment screw;u000bimplant connecting part;u000bimplant connecting part screw;u000bprosthetic screw;u000bimplant cover screw;u000btransmucosal healing component.u000bu000b

This document also specifies requirements for intended use and performance, design attributes, components, biocompatibility, manufacturing, packaging, sterilization, shelf life, marking, labelling and information supplied by the manufacturer.

u000b

This document does not apply to the following devices:

u000bu000bdental implants incorporating animal or human components or bioactive characteristics;u000bcustom-made devices that have no pre-fabricated connection;u000bimplantable materials for bone filling and augmentation in oral and maxillofacial surgery;u000bmembrane materials for guided tissue regeneration in oral and maxillofacial surgery;u000bspecific instruments indicated to be used as part of a dental implant system.u000bu000b

NOTE 1 ISO 22794 specifies the necessary content of technical files for implantable materials for bone filling and augmentation in oral and maxillofacial surgery. ISO 22803 specifies 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.

u000b

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.

u000b

NOTE 3 Custom-made devices are defined in IMDRF/PMD WG/N49 [5].

Product Details

Published:

03/01/2026

File Size:

1 file , 410 KB

Note:

This product is restricted and cannot be purchased in the following countries Ukraine, Russia, Belarus