# K093483: Atlantis Abutment for Nobel Biocare Active Implant, Atlantis Gemini Abutment, Gemini + Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Astra Tech, Inc.
- Decided: Dec 22, 2009 after 43 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 K894595 (1990). 26 ancestors in all.
67 later devices descend from it; 2 cite it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071370: Nobelactive Internal Connection Implant, Nobel Biocare AB (2007) Summary page 1.
- K072129: Nobelactive Zirconia Abutment, Nobel Biocare AB (2008) Summary page 1.

## Most influential descendants
- K111935: TI-Base Abutment, 1 Connect Abutment (2012), 64 descendants of its own
- K132219: Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN, Straumann (R) Variobase (TM) Abutment WN, (2014), 35 descendants of its own
- K142890: Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit (2015), 30 descendants of its own
- K122295: Core 3D Abutment System for Digital Prosthetic Solutions (2013), 29 descendants of its own
- K151621: BioHorizons CAD/CAM Abutments (2016), 26 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 abutmefit. 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 and zirconia abutments are compatible with the Nobel Biocare's NobelActive 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. 3 0 degrees) on implants with diameters less than 4 rmm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the ipat

Source page: https://510kreport.com/device/K093483
Methodology: https://510kreport.com/methodology