Atlantis® Abutments in Titanium

The Atlantis® Abutments in Titanium are custom dental abutments designed to connect endosseous dental implants to prosthetic restorations in patients with missing teeth. They support single or multiple tooth replacements in the upper or lower jaw to restore chewing function. The abutments are patient-specific, designed using CAD technology from dental models, and can be manufactured internally or designed through FDA-cleared 3Shape software before manufacturing.

Key differences from the predicate include: MR safety labeling updated from MR Not Evaluated to MR Conditional; addition of Angulated Screw Access (ASA) feature allowing lingual-side screw access on some abutments; expansion to include Healing, Conus, and Crown Abutment variants not originally cleared with all implant compatibilities; minor screw diameter standardizations; and addition of Atlantis Abutment Milling option via 3Shape software design. All abutments remain titanium or gold-shaded titanium with internal/external hexagonal or conical connections depending on implant type.

ASTM F2052-21 (magnetic displacement force); ASTM F2213-17 (magnetically induced torque); ASTM F2119-07 (MR image artifacts); ASTM F2503-20 (MR safety marking); ISO 10993-1:2018 and ISO 10993-5:2009 (biocompatibility); ISO 14801:2016 (dynamic loading/fatigue); ANSI/AAMI/ISO 17665-1 and 14937 (sterilization validation); FDA guidance on MR environment testing and reprocessing.

The proposed devices have identical intended use and similar indications to predicate K193529. MR Conditional labeling is supported by worst-case testing on Dentsply Sirona implant products per FDA MR guidance, referenced to K221094 testing data. Minor design changes (ASA feature, diameter modifications, abutment variant expansion) either fall within previously tested design envelopes, maintain existing connection geometry validated under ISO 14801, or are supported by software validation confirming design limitations match internal CAD constraints. No new fatigue testing was required because modifications do not affect device performance, and existing predicate/reference device test data remain applicable.