# K041509: Ankylos Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Friadent GmbH
- Decided: Aug 26, 2004 after 80 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K894595 (1990). 16 ancestors in all.
325 later devices descend from it; 10 cite it directly.
0 of 342 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032158: Xive Dental Implant System Multiple, Friadent GmbH (2003) Summary page 1.
- K021318: Xive Dental Implant System, Friadent GmbH (2002) Summary page 1.

## Cited in the summary but kept off the family tree
- K012087: Cordis Palmaz Genesis Transhepatic Biliary Stent, Cordis Corp. (2001). Our reading of the summary gave K012087, FDA’s number for Cordis Palmaz Genesis Transhepatic Biliary Stent (Cordis Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “ANKYLOS® Dental Implant System”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K083805: Ankylos C/X Dental Implant System (2009), 290 descendants of its own
- K101004: Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis Gemini + Abutment (2010), 199 descendants of its own
- K120338: Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in Zirconia (2012), 197 descendants of its own
- K120414: Osseospeed Plus (2012), 196 descendants of its own
- K101945: Neodent Implant System (2011), 180 descendants of its own

## Indications for use
An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforaminal placed implants, and not indicated for single, unsplinted implants. Patients must be subject for dental treatment with endosseous implants.

Source page: https://510kreport.com/device/K041509
Methodology: https://510kreport.com/methodology