# K250081: Atlantis® Abutments in Titanium - Pathway: 510(k) (Traditional) - Applicant: Dentsply Sirona - Decided: Apr 11, 2025 after 88 days - Product code: NHA (Abutment, Implant, Dental, Endosseous) - Device class: 2 - Regulation: 21 CFR 872.3630 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 16 generations back to K894595 (1990). 162 ancestors in all. 2 later devices descend from it; 2 cite it directly. 0 of 165 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K193529: ATLANTIS Abutment for MIS Conical Connection Implants, Dentsply Sirona (2020) Summary page 6. ## Most influential descendants - K252343: Atlantis® Abutments in Titanium (2025), 0 descendants of its own - K251205: Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants (2025), 0 descendants of its own ## Indications for use Atlantis Abutment & Atlantis Abutment Milling The Atlantis Abutment and Atlantis Abutment Milling are intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant. Atlantis Crown Abutment The Atlantis Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The Atlantis Abutment screw is intended to secure the Atlantis Crown Abutment to the endosseous implant. Atlantis Conus Abutment The Atlantis Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is an attachment- retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant. Atlantis Healing Abutment The Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The Atlantis Abutment screw is intended to secure the Atlantis Healing Abutment to the endosseous implant. Implant Manufacturer: Dentsply Sirona Implant System: OsseoSpeed/OsseoSpeed TX Implant Diameter (in mm): 3.0 (Yellow), 3.5, 4.0 (Aqua), 4.5, 5.0 (Lilac), 4.0 (Blue - Previous) Abutment Platform Diameter (in mm): 2.330 (Yellow), 2.866 (Aqua), 3.865 (Lilac), 3.368 (Blue - Previous) Implant Manufacturer: MIS Implant Technologies Inc. Implant System: V3 (NP, SP), C1 (NP, SP, WP) Implant Diameter (in mm): V3: 3.30 (NP), 3.90, 4.3, 5.0 (SP); C1: 3.30 (NP), 3.75, 4.2 (SP), 5.0 (WP) Abutment Platform Diameter (in mm): V3: 2.765 (NP), 3.16 (SP); C1: 2.76 (NP), 3.16 (SP), 4.01 (WP) Implant Manufacturer: Altatec GmbH Implant System: Conelog Screw-Line Implant Implant Diameter (in mm): 3.3, 3.8, 4.3, 5.0 Abutment Platform Diameter (in mm): 2.80 (3.3), 3.00 (3.8, 4.3), 3.80 (5.0) Implant Manufacturer: Nobel Biocare Implant System: NobelActive Implant Diameter (in mm): 3.0 Abutment Platform Diameter (in mm): 2.461 Implant System: Branemark System (NP, RP, WP) Implant Diameter (in mm): 3.3 (NP), 3.75, 4.0 (RP), 5.0, 5.5 (WP) Abutment Platform Diameter (in mm): 3.476 (NP), 4.069 (RP), 5.033 (WP) Implant Manufacturer: BioHorizons Implant System: Prodigy System Internal/Tapered Internal Implant Diameter (in mm): 3.5, 4.5, 5.7 Abutment Platform Diameter (in mm): 3.434 (3.5), 4.399 (4.5), 5.644 (5.7) Implant System: Maestro Implant Diameter (in mm): 3.5, 4.0, 5.0 Abutment Platform Diameter (in mm): 3.708 (3.5), 4.242 (4.0), 5.258 (5.0) Implant Manufacturer: Biomet 3i Implant System: Certain, Certain Prevail, Certain XP Implant Diameter (in mm): Certain: 3.25, 4, 5, 6; Certain Prevail: 3.4, 4, 5; Certain XP: 5, 6 Abutment Platform Diameter (in mm): 3.404 (3.25, 3.4), 4.012 (4), 4.942 (5), 5.951 (6) Implant System: Osseotite Tapered and Osseotite Parallel Walled Implant Diameter (in mm): 3.25, 3.75, 4.0, 5.0, 6.0 Abutment Platform Diameter (in mm): 4.056 (3.25, 3.75, 4.0), 4.978 (5.0), 5.985 (6.0) Source page: https://510kreport.com/device/K250081 Methodology: https://510kreport.com/methodology