# K040946: Ankylos Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Friadent GmbH
- Decided: Jul 1, 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: 4 generations back to K894595 (1990). 11 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012681: Ankylos, Dentsply Ceramco (2003) Summary page 1.

## Most influential descendants
- K040757: Sic Pro (2005), 2 descendants of its own
- K061500: Sicace Dental Implant System and Sic Angled Abutments (2006), 1 descendant of its own
- K073622: Easy Grip Dental Implant System (2008), 0 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 healling 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 interforminal 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/K040946
Methodology: https://510kreport.com/methodology