# K172225: Atlantis Abutment for MIS Implant

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Nov 30, 2017 after 128 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: 14 generations back to K894595 (1990). 160 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 169 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160626: ATLANTIS Abutment for HIOSSEN ET implant, Dentsply Sirona (2016) Summary page 4.
- K040807: Mis Dental Implant System, Mis - Implant Technologies, Ltd. (2004) Summary page 4.
- K103089: Seven Implants; Biocom Implants; Lance Implants, Mis - Implant Technologies, Ltd. (2011) Summary page 4.

## Most influential descendants
- K203660: TRI-matrix Implant Line (2021), 3 descendants of its own
- K193529: ATLANTIS Abutment for MIS Conical Connection Implants (2020), 3 descendants of its own
- 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. ATLANTIS® Abutment for MIS implant is compatible with MIS implant from MIS Implant System. MIS short implants (6mm) are to be used only with straight abutments. ATLANTIS® products are compatible with the implants shown in the table below. Implant manufacturer — MIS-IMPLANT TECHNOLOGIES INC Trade Name: MIS Implant M4 & SEVEN Narrow Platform; Abutment Platform Diameter: 3.30 mm; Implant Diameter: 3.30 mm Trade Name: MIS Implant M4 & SEVEN Standard Platform; Abutment Platform Diameter: 3.75 and 4.2 mm; Implant Diameter: 3.75 and 4.2 mm Trade Name: MIS Implant M4 & SEVEN Wide Platform; Abutment Platform Diameter: 5.0 and 6.0 mm; Implant Diameter: 5.0 and 6.0 mm

Source page: https://510kreport.com/device/K172225
Methodology: https://510kreport.com/methodology