# K103020: Atlantis Abutment for Keystone Implant, Atlantis Gemini Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Atlantis Components, Inc.
- Decided: Feb 3, 2011 after 114 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: 11 generations back to K960026 (1996). 45 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051614: Primaconnex Internal Connection Implant System, Primaconnex Internal Connection Prosthetics, Lifecore Biomedical, Inc. (2005) Summary page 2.
- K062876: Primaconnex Ceramic Abutments, Lifecore Biomedical, Inc. (2006) Summary page 2.

## Most influential descendants
- K161713: Dentium CAD/CAM Abutments (2016), 3 descendants of its own
- K251605: DIMPLO Implant System (2025), 0 descendants of its own
- K221972: Warantec Custom Abutment (2023), 0 descendants of its own
- K171622: Dentium Ti-Base (2018), 0 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' im~plant systems: The titanium abutments are compatible with the Keystone 3.5mm, 4.0mm, 4.1mmu and 5.0mm. Kezstone Implants. The zirconia abutments are compatible with the Keystone 3.5mm, 4.0mm, 4. 1mm and 5.0min Keystone 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 only.

Source page: https://510kreport.com/device/K103020
Methodology: https://510kreport.com/methodology