Atlantis® Abutments in Titanium

The Atlantis® Abutments in Titanium are custom dental abutments designed to connect endosseous implants to prosthetic restorations (crowns, bridges, overdentures) in patients with missing teeth. The abutments are manufactured using computer-assisted design and manufacturing based on patient dental models and are available in four variants: standard Abutment, Crown Abutment, Conus Abutment, and Healing Abutment, compatible with multiple implant systems from various manufacturers.

The primary change is modification of labeling from MR Not Evaluated to MR Conditional. Additional changes include: addition of Angulated Screw Access (ASA) features to some abutments; expansion of Healing, Conus, and Crown Abutment offerings to previously uncovered implant interfaces; expanded compatibility with additional implant systems using the same connection types; minor dimensional modifications to abutments and screws; and addition of an Atlantis Abutment Milling workflow using FDA-cleared 3Shape design software. All changes remain within the established design envelope.

ASTM F2052-21 (magnetically induced displacement force), ASTM F2213-17 (magnetically induced torque), ASTM F2119-07 (MR image artifacts), ASTM F2503-20 (MR safety marking), ISO 10993-1:2018 (biocompatibility evaluation), ISO 14801:2016 (dynamic loading fatigue test), AAMI ST98:2022 (cleaning validation), ANSI/AAMI/ISO 17665-1:2006, and FDA guidance on MR testing and reprocessing.

The proposed devices have identical intended use and similar indications to predicate device K250081. The primary change—MR Conditional labeling—is supported by testing from the predicate device that demonstrated compliance with MR safety standards. All other changes were either already implemented in the predicate device or do not constitute new worst-case constructs; existing fatigue and biocompatibility testing remains valid. Reference to prior clearances and predicate testing confirms the changes do not raise new safety or effectiveness questions.