# K112138: Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant

- Pathway: 510(k) (Traditional)
- Applicant: Astra Tech, Inc.
- Decided: Dec 1, 2011 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: 10 generations back to K894595 (1990). 46 ancestors in all.
200 later devices descend from it; 3 cite it directly.
0 of 247 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111287: Astra Tech Implant System, Astra Tech AB (2011). Cleared while this submission was under review Summary page 3.
- K071946: Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra Implants, Atlantis Components, Inc. (2007) Summary page 2.

## Most influential descendants
- K120414: Osseospeed Plus (2012), 196 descendants of its own
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own
- K173908: DESS Dental Smart Solutions (2018), 51 descendants of its own
- K150295: LOCATOR RTx (2015), 42 descendants of its own
- K191986: DESS Dental Smart Solutions (2019), 38 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 abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: The Atlantis Abutment in Zirconia for Astra Tech Osseospeed Implant is compatible with the Astra Tech Osseospeed Plus 3.6mm and 4.2mm Implants. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments on small diameter implants are intended for the anterior region of the mouth only.

Source page: https://510kreport.com/device/K112138
Methodology: https://510kreport.com/methodology