For immediate release, October 6, 2017: PaxMed International announces FDA 510(k) clearance, on behalf of Thommen Medical AG of Grenchen, Switzerland, of the ELEMENT Ø 3.0 self-tapping, root form, endosseous dental implant and abutments.
ELEMENT Ø 3.0 is a self-tapping, root form, endosseous dental implant made of commercially pure titanium, available in two surfaces (TST and INICELL) and five lengths (8.0, 9.5, 11.0, 12.5, and 14 mm). Components available for the ELEMENT Ø 3.0 implant include a healing cap, gingiva former and VARIOunite abutments. VARIOunite abutments can be used for temporary restorations, permanent restorations, or CAD/CAM zirconia superstructures. Significantly, this clearance also expands the indications for previously cleared VARIOunite abutments to include CAD/CAM zirconia superstructures.
This clearance marks PaxMed’s 197th clearance, of which 26 have been for Thommen Medical. It also is the 63rd clearance for PaxMed’s dental implant specialist, Linda Schulz.