# K110356: Atlantis Crown Abutment, Atlantis Gemini +(TM) Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Astra Tech, Inc.
- Decided: Jun 10, 2011 after 123 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: 6 generations back to K925765 (1993). 21 ancestors in all.
202 later devices descend from it; 4 cite it directly.
0 of 224 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071946: Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra Implants, Atlantis Components, Inc. (2007) Summary page 3.

## Most influential descendants
- 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
- K191986: DESS Dental Smart Solutions (2019), 38 descendants of its own

## Indications for use
The Atlantis Crown Abutment in Zirconia is intended for use with an endosseus implant to function as a substructure that also serves as the final restoration, in a partilly or completely edentulous patient. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: Astra Tech Microthread ST 3.5mm, 4.0mm, 4.5mm and 5.0mmn 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 of the mouth only.

Source page: https://510kreport.com/device/K110356
Methodology: https://510kreport.com/methodology