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EVS-EN ISO 10451:2010

Dentistry - Contents of technical file for dental implant systems

General information
Valid from 04.10.2010
Base Documents
ISO 10451:2010; EN ISO 10451:2010
Directives or regulations
None
Standard history
Status
Date
Type
Name
This International Standard specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for a dental implant and any prefabricated part thereof that remains in the mouth after surgery. This International Standard is not applicable to instruments and other parts specifically made for the dental implant system but which do not remain in the mouth. However, documentation relating to these components may be included in the technical file.
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