# K193529: ATLANTIS Abutment for MIS Conical Connection Implants

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Mar 5, 2020 after 76 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: 15 generations back to K894595 (1990). 161 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K172225: Atlantis Abutment for MIS Implant, Dentsply Sirona (2017) Summary page 5.

## Most influential descendants
- K250081: Atlantis® Abutments in Titanium (2025), 2 descendants of its own
- 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
The ATLANTIS® Abutment is 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 mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the ATLANTIS® Abutment to the endosseous implant. 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 abutment screw is intended to secure the ATLANTIS® Crown Abutment to the endosseous implant. 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 attachment-retained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS® Conus Abutment to the endosseous implant. The ATLANTIS® Healing Abutment can be used with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The abutment screw is intended to secure the ATLANTIS® Healing Abutment to the endosseous implant. ATLANTIS® Abutment is compatible with MIS Conical Connection implant from MIS Implant System. ATLANTIS® products are compatible with the implants shown in the table below. Implant manufacturer - MIS-IMPLANT TECHNOLOGIES INC Trade Name Abutment Platform Diameter Implant Diameter Atlantis Abutment for MIS V3 NP 02.765mm V3: ¥3.30 mm Atlantis Abutment for MIS C1 NP 2. 76mm Cl: @¥3.30 mm Atlantis Abutment for MIS C1 & V3 SP ©@3.16mm Cl: 93.75,42 mm, V3: ©03.90,4.3,5.0 mm Atlantis Abutment for MIS C1 WP 04.0Imm Cl: 95.0 mm

Source page: https://510kreport.com/device/K193529
Methodology: https://510kreport.com/methodology