# K072483: Atlantis Abutment in Zirconia for 3I Certain Microamini Implants, Gemini Abutment in Zirconia for Astra Implants

- Pathway: 510(k) (Traditional)
- Applicant: Atlantis Components, Inc.
- Decided: Nov 16, 2007 after 73 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). 54 ancestors in all.
28 later devices descend from it; 1 cites it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062069: Atlantis Abutment for 3I Micromini Implant, Atlantis Components, Inc. (2007) Summary page 1.
- K063734: Atlantis Abutment in Zirconia for 3I Certain Interface, Atlantis Components, Inc. (2007) Summary page 1.
- K014235: Osseotite NT Dental Implants & Accessories, Implant Innovations, Inc. (2002) Summary page 1.

## Most influential descendants
- K083480: Inclusive Zirconia Abutment Blanks (2009), 27 descendants of its own
- K132125: A.B. Dental Devices Dental Implants System (2014), 25 descendants of its own
- K140440: Noris Medical Dental Implants System (2014), 14 descendants of its own
- K151909: Noris Medical Zygomatic Dental Implant System (2016), 7 descendants of its own
- K162482: A.B. DENTAL DEVICES Dental Implants System (2017), 4 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 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: 3i Osseotite NT® CertainTM and 3i Osseotite® CertainTm (parallel Walled) 3.25mm diameter 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. Also, 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/K072483
Methodology: https://510kreport.com/methodology