This document specifies requirements of polymeric materials used to fabricate dental implant surgical guides produced through additive manufacturing and the test methods to be used in determining compliance with these requirements. It also specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for use of these materials. Requirements related to the surgical guide but irrelevant to polymeric materials used for dental implant surgical guide fabrication (e.g. requirements related to the manufacturing process or interoperability during data transfer) are excluded. Also, surgical guides produced by heat processing or milling, and metallic materials used in the surgical guide are excluded from the scope
Registration number (WIID)
82017
Scope
This document specifies requirements of polymeric materials used to fabricate dental implant surgical guides produced through additive manufacturing and the test methods to be used in determining compliance with these requirements. It also specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for use of these materials. Requirements related to the surgical guide but irrelevant to polymeric materials used for dental implant surgical guide fabrication (e.g. requirements related to the manufacturing process or interoperability during data transfer) are excluded. Also, surgical guides produced by heat processing or milling, and metallic materials used in the surgical guide are excluded from the scope
