# K151039: ATLANTIS Abutment for NobelActive 3.0

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International, Inc.
- Decided: Jan 14, 2016 after 269 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). 158 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 160 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093483: Atlantis Abutment for Nobel Biocare Active Implant, Atlantis Gemini Abutment, Gemini + Abutment, Astra Tech, Inc. (2009) Summary page 6.
- K130999: Osseospeed Profile EV, Dentsply Implants Manufacturing GmbH (2013) Summary page 4.
- K102436: Nobel Active 3.0, Nobel Biocare AB (2010) Summary page 4.

## Most influential descendants
- K161030: ATLANTIS Abutment for CONELOG implant (2016), 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 the 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 NobelActive 3.0 is compatible with the NobelActive 3.0 implant.

Source page: https://510kreport.com/device/K151039
Methodology: https://510kreport.com/methodology