# K071946: Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra Implants

- Pathway: 510(k) (Traditional)
- Applicant: Atlantis Components, Inc.
- Decided: Oct 5, 2007 after 84 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). 20 ancestors in all.
209 later devices descend from it; 5 cite it directly.
0 of 230 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.
- K053384: Fixature Microthread Osseospeed, a Component of the Astra Tech Implant System, Astra Tech, Inc. (2006) Summary page 1.
- K024111: Astra Tech Implants-Dental System Fixture Osseospeed, Astra Tech, Inc. (2003) Summary page 1.

## Most influential descendants
- K110356: Atlantis Crown Abutment, Atlantis Gemini +(TM) Abutment (2011), 202 descendants of its own
- K112138: Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant (2011), 200 descendants of its own
- K101005: Astra Tech Implant System, New Component (2011), 198 descendants of its own
- K120414: Osseospeed Plus (2012), 196 descendants of its own
- K170588: DESS Dental Smart Solutions (2017), 86 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 cement 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: Astra Tech Systems OsseoSpeedTM Implants 3.5 mm, 4.0mm, 4.5 mm and 5.0 mm diameters. 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. Also, 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/K071946
Methodology: https://510kreport.com/methodology