# K052070: Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis Gemeini + Abutment in Zirconia

- Pathway: 510(k) (Traditional)
- Applicant: Atlantis Components, Inc.
- Decided: Oct 14, 2005 after 74 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: 7 generations back to K944964 (1995). 39 ancestors in all.
261 later devices descend from it; 7 cite it directly.
0 of 301 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042658: Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004, Nobel Biocare Uas, Inc. (2004) Summary page 1.

## Most influential descendants
- K093780: Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis Gemini + Abutment (2010), 200 descendants of its own
- K101004: Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis Gemini + Abutment (2010), 199 descendants of its own
- 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

## Indications for use
The Atlantis Abutment is intended for use as an accessory to 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 having an external hex with fiat-to-flat dimensions of 2.7mm or greater: Nobel Biocare, 3i, Lifecore, Sterngold ImplaMed, Innova, and BioHorizons. 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.

Source page: https://510kreport.com/device/K052070
Methodology: https://510kreport.com/methodology