# K053373: Atlantis Abutment for Zimmer Interface

- Pathway: 510(k) (Traditional)
- Applicant: Atlantis Components, Inc.
- Decided: Jun 30, 2006 after 207 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: 2 generations back to K931468 (1994). 4 ancestors in all.
13 later devices descend from it; 5 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981858: Atlantis Abutment and Atlantis Abutment Screw, Atlantis Components, Inc. (1999) Summary page 1.
- K011028: Screw-Vent Dental Implant System, Sulzer Dental, Inc. (2001) Summary page 1.

## Most influential descendants
- K072241: Primaconnex Cad/Cam Abutment System (2007), 7 descendants of its own
- K103339: TDS Abutment for Friadent Xive (2011), 3 descendants of its own
- K073258: Atlantis Abutment for Biohorizon Implants, Atlantis Gemini Abutment for Biohorizon Implants, Atlantis Gemini + Abutment (2008), 3 descendants of its own
- K110778: Biodenta Customized Abutment (2011), 2 descendants of its own
- K151295: Biodenta Customized Abutment - Titanium (2015), 1 descendant 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. 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 umm are intended for the anterior region of the mouth and are not intended for the posterior region due to the limited strength of the implant.

Source page: https://510kreport.com/device/K053373
Methodology: https://510kreport.com/methodology