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ISO 10451:2026 versus ISO 10451:2010

Name: ISO Compliance Reports & Standards Comparisons - STANC
Availability: InStock

Dentistry — Contents of a technical file for dental implant systems

General information

Valid from 10.10.2026

Directives or regulations

none

Documents

DHF-IMPACT-ANALYSIS

$55.00 including VAT

HANDBOOK

$30.00 including VAT

STD-GAP-ANALYSIS

$90.00 including VAT

Total:

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

implant body;
implant abutment;
abutment screw;
implant connecting part;
implant connecting part screw;
prosthetic screw;
implant cover screw;
transmucosal healing component.

This standard 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. This document does not apply to the following devices:

dental implants 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

ISO 10451:2026 versus ISO 10451:2010

Price range: $30.00 through $90.00

Dentistry — Contents of a technical file for dental implant systems

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SKU: N/A Categories: Healthcare, ISO