# K103759: Atlantis Abutment in Zirconia for Osseospeed TX Profile Implant

- Pathway: 510(k) (Traditional)
- Applicant: Astra Tech, Inc.
- Decided: Apr 8, 2011 after 106 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: 6 generations back to K925765 (1993). 22 ancestors in all.
19 later devices descend from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080156: Osseospeed TM  Profile System, Astra Tech AB (2008) Summary page 3.
- K071946: Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra Implants, Atlantis Components, Inc. (2007) Summary page 4.

## Most influential descendants
- K130999: Osseospeed Profile EV (2013), 18 descendants of its own
- K160626: ATLANTIS Abutment for HIOSSEN ET implant (2016), 9 descendants of its own
- K172225: Atlantis Abutment for MIS Implant (2017), 8 descendants of its own
- K160207: ATLANTIS ISUS Implant Suprastructures (2016), 5 descendants of its own
- K163350: Multibase Abutments EV and ATLANTIS Suprastructures (2017), 4 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 is compatible with the Astra Tech Osseospeed TX Profile 4.5, 5.0 and 5.0 S 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/K103759
Methodology: https://510kreport.com/methodology