# K160626: ATLANTIS Abutment for HIOSSEN ET implant

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Aug 29, 2016 after 175 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: 13 generations back to K894595 (1990). 154 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 164 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130999: Osseospeed Profile EV, Dentsply Implants Manufacturing GmbH (2013) Summary page 4.

## Most influential descendants
- K172225: Atlantis Abutment for MIS Implant (2017), 8 descendants of its own
- 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

## 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™ products are compatible with the implants shown in the table below. Implant Manufacturer - HIOSSEN INC Trade Name Abutment Platform Diameter Implant Diameter HIOSSEN ET III SA Fixture Mini 93,5mm 93,5mm HIOSSEN ET III SA Fixture Regular ©4.0, 4.5, 5.0, 6.0, 7.0 mm 04.0,4.5,5.0, 6.0, 7.0 mm

Source page: https://510kreport.com/device/K160626
Methodology: https://510kreport.com/methodology