# K081666: Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 Implants

- Pathway: 510(k) (Traditional)
- Applicant: Astra Tech, Inc.
- Decided: Oct 7, 2008 after 116 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: 5 generations back to K925765 (1993). 21 ancestors in all.
337 later devices descend from it; 4 cite it directly.
0 of 359 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070833: Atlantis Abutment for Astra Implant, Atlantis Components, Inc. (2007) Summary page 1.
- K080396: Osseospeed Narrow, Astra Tech AB (2008) Summary page 1.

## Most influential descendants
- K100152: Sirona Cad/Cam System (2010), 240 descendants of its own
- K120414: Osseospeed Plus (2012), 196 descendants of its own
- K120822: Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann Cares Variobase Abutment WN, ST (2012), 165 descendants of its own
- K150203: Medentika CAD/CAM Abutments (2015), 129 descendants of its own
- K150367: Neodent Implant System (2015), 89 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 maxillary lateral incisors and mandibular lateral and central incisors. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the Astra Tech OsseoSpeed 3.0 mm Implant. 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 (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the Implant.

Source page: https://510kreport.com/device/K081666
Methodology: https://510kreport.com/methodology