<p><span lang="EN-GB">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:</span></p>
<ul>
<li><span lang="EN-GB">implant body;</span></li>
<li><span lang="EN-GB">implant abutment;</span></li>
<li><span lang="EN-GB">abutment screw;</span></li>
<li><span lang="EN-GB">implant connecting part;</span></li>
<li><span lang="EN-GB">implant connecting part screw;</span></li>
<li><span lang="EN-GB">prosthetic screw;</span></li>
<li><span lang="EN-GB">implant cover screw;</span></li>
<li><span lang="EN-GB">transmucosal healing component.</span></li>
</ul>
<p><span lang="EN-GB">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.</span></p>
<p><span lang="EN-GB">This document does not apply to the following devices:</span></p>
<ul>
<li><span lang="EN-GB">dental implants incorporating animal or human components or bioactive characteristics;</span></li>
<li><span lang="EN-GB">custom-made devices that have no pre-fabricated connection;</span></li>
<li><span lang="EN-GB">implantable materials for bone filling and augmentation in oral and maxillofacial surgery;</span></li>
<li><span lang="EN-GB">membrane materials for guided tissue regeneration in oral and maxillofacial surgery;</span></li>
<li><span lang="EN-GB">specific instruments indicated to be used as part of a dental implant system.</span></li>
</ul>
<p><span lang="EN-GB">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.</span></p>
<p><span lang="EN-GB">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.</span></p>
<p><span lang="EN-GB">NOTE 3 Custom-made devices are defined in IMDRF/PMD WG/N49 </span>[5]<span lang="EN-GB">.</span></p>
Registration number (WIID)
83843
Scope
<p><span lang="EN-GB">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:</span></p>
<ul>
<li><span lang="EN-GB">implant body;</span></li>
<li><span lang="EN-GB">implant abutment;</span></li>
<li><span lang="EN-GB">abutment screw;</span></li>
<li><span lang="EN-GB">implant connecting part;</span></li>
<li><span lang="EN-GB">implant connecting part screw;</span></li>
<li><span lang="EN-GB">prosthetic screw;</span></li>
<li><span lang="EN-GB">implant cover screw;</span></li>
<li><span lang="EN-GB">transmucosal healing component.</span></li>
</ul>
<p><span lang="EN-GB">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.</span></p>
<p><span lang="EN-GB">This document does not apply to the following devices:</span></p>
<ul>
<li><span lang="EN-GB">dental implants incorporating animal or human components or bioactive characteristics;</span></li>
<li><span lang="EN-GB">custom-made devices that have no pre-fabricated connection;</span></li>
<li><span lang="EN-GB">implantable materials for bone filling and augmentation in oral and maxillofacial surgery;</span></li>
<li><span lang="EN-GB">membrane materials for guided tissue regeneration in oral and maxillofacial surgery;</span></li>
<li><span lang="EN-GB">specific instruments indicated to be used as part of a dental implant system.</span></li>
</ul>
<p><span lang="EN-GB">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.</span></p>
<p><span lang="EN-GB">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.</span></p>
<p><span lang="EN-GB">NOTE 3 Custom-made devices are defined in IMDRF/PMD WG/N49 </span>[5]<span lang="EN-GB">.</span></p>
