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Standards Development
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.
The dimensions/tolerances of the abutment screw and the interface connections between the implant body and abutments are critical to the mechanical stability of the implant system. When a single manufacturer produces the dental implant, the dental implant abutment and dental implant abutment, this primary manufacturer has complete control over component dimensions and tolerances. If a secondary manufacturer intends to produce components and claim compatibility with the primary manufacturer’s components, dimensions and tolerances of the primary manufacturer’s components may not be known. In this case, a reverse engineering analysis is necessary to determine dimensions and tolerances of the interconnecting components to establish mechanical compatibility between components.
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