# K012681: Ankylos

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Ceramco
- Decided: Aug 22, 2003 after 738 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: 3 generations back to K894595 (1990). 10 ancestors in all.
7 later devices descend from it; 3 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)
- K984104: Iti Dental Implant System, Straumann USA (1999) Summary page 1.
- K992937: Dental Implant, Nobel Biocare Uas, Inc. (2000) Summary page 1.

## Most influential descendants
- K040946: Ankylos Dental Implant System (2004), 3 descendants of its own
- K040757: Sic Pro (2005), 2 descendants of its own
- K081226: Simpact Implant System (2008), 1 descendant of its own
- K061500: Sicace Dental Implant System and Sic Angled Abutments (2006), 1 descendant of its own
- K083141: Simpact Endosseous Dental Implant System (2008), 0 descendants of its own

## Indications for use
An endosseous dental implant is indicated for surgical placement in the upper or 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. Patient must be subject for dental treatment with endosseous implants

Source page: https://510kreport.com/device/K012681
Methodology: https://510kreport.com/methodology