# K053450: Atlantis Abutment for Zimmer Interface

- Pathway: 510(k) (Traditional)
- Applicant: Atlantis Components, Inc.
- Decided: Mar 3, 2006 after 81 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 K944964 (1995). 40 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052070: Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis Gemeini + Abutment in Zirconia, Atlantis Components, Inc. (2005) Summary page 1.

## Cited in the summary but kept off the family tree
- K061028: Precision Thunis 800+, Ge Medical Systems, LLC (2006). Our reading of the summary gave K061028, which FDA decided on Jun 7, 2006, after this device was decided (Mar 3, 2006), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree.

## Most influential descendants
- K073540: Atlantis Abutment in Zirconia for Biohorizons Implant (2008), 1 descendant 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 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: Zimmer Dental, Nobel Biocare, 3i, Lifecore, Stemgold, 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/K053450
Methodology: https://510kreport.com/methodology