# K101004: Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis Gemini + Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Astra Tech, Inc.
- Decided: Aug 16, 2010 after 126 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: 9 generations back to K944964 (1995). 61 ancestors in all.
199 later devices descend from it; 2 cite it directly.
0 of 261 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083805: Ankylos C/X Dental Implant System, Dentsply Intl., Inc. (2009) Summary page 1.
- K093780: Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis Gemini + Abutment, Astra Tech, Inc. (2010). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K120338: Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in Zirconia (2012), 197 descendants of its own
- 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

## 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 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 titanium abutments are compatible with the Dentsply 3.5mm, 4.5mm, 5.5mm and 7.0mm Ankylos 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 (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/K101004
Methodology: https://510kreport.com/methodology