# K073258: Atlantis Abutment for Biohorizon Implants, Atlantis Gemini Abutment for Biohorizon Implants, Atlantis Gemini + Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Atlantis Components, Inc.
- Decided: Feb 14, 2008 after 86 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: 8 generations back to K960026 (1996). 15 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053373: Atlantis Abutment for Zimmer Interface, Atlantis Components, Inc. (2006) Summary page 1.
- K042429: The Prodigy System Dental Implants, BioHorizons Implant Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- K103234: GC Aadva BO AC Abutments (2011), 1 descendant of its own
- K141970: Digitek Titanium Abutment (2015), 0 descendants of its own
- K113816: GC Aadva Abutment- Zirconium-BO AC BH SV (2013), 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 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: BioHorizons The Prodigy System Tm Dental Implants 3.5mm, 4.0mm, 5.0mm and 6.0mm 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. 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/K073258
Methodology: https://510kreport.com/methodology