This document specifies measurement methods to demonstrate the physical dimensional compatibility of the interface between an implant body and an implant abutment and the dental abutment fixation screw in a dental implant system.
The following devices are not included within the scope of this document:
• Endosseous dental implant or components with implant bodies without an axial symmetry and not inserted axially,
• Monopart implant systems,
• Dental implant incorporating animal or human components,
• Surgically implantable dental materials defined as restorative materials,
• Specific instruments indicated to be used as part of a dental implant system.
Analog or replica components cannot be used to evaluate the physical compatibility of dental implant system components.
Additional performance measurements or mechanical testing may be required to determine suitability for intended use.
Registration number (WIID)
82022
Scope
This document specifies measurement methods to demonstrate the physical dimensional compatibility of the interface between an implant body and an implant abutment and the dental abutment fixation screw in a dental implant system.
The following devices are not included within the scope of this document:
• Endosseous dental implant or components with implant bodies without an axial symmetry and not inserted axially,
• Monopart implant systems,
• Dental implant incorporating animal or human components,
• Surgically implantable dental materials defined as restorative materials,
• Specific instruments indicated to be used as part of a dental implant system.
Analog or replica components cannot be used to evaluate the physical compatibility of dental implant system components.
Additional performance measurements or mechanical testing may be required to determine suitability for intended use.
