# K130216: Atlantis Straumann Bone Level Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Implant
- Decided: May 1, 2013 after 92 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: 10 generations back to K894595 (1990). 101 ancestors in all.
No later device cites it as a predicate yet.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083871: Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment, Atlantis Gemini + Straumann Bone, Astra Tech, Inc. (2009) Summary page 2.
- K110356: Atlantis Crown Abutment, Atlantis Gemini +(TM) Abutment, Astra Tech, Inc. (2011) Summary page 2.
- K083550: Straumann Dental Implant System, Straumann USA (2009) Summary page 2.
- K062129: P.0004 Implants, Institut Straumann AG (2006) Summary page 2.

## 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 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 partially or completely edentulous patients. The abutment screw is intended to secure the crown abutment to the endosseous implant. Atlantis Straumann Bone Level Abutment in Zirconia is compatible with the 03.3 mm Straumann Bone Level Implant.

Source page: https://510kreport.com/device/K130216
Methodology: https://510kreport.com/methodology