# K083805: Ankylos C/X Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl., Inc.
- Decided: May 22, 2009 after 151 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: 7 generations back to K894595 (1990). 20 ancestors in all.
290 later devices descend from it; 8 cite it directly.
0 of 311 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041509: Ankylos Dental Implant System, Friadent GmbH (2004) Summary page 1.
- K073075: Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant Systems, Dentsply International, Inc. (2008) Summary page 1.

## Most influential descendants
- 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
- K123022: Neodent Implant System (2013), 127 descendants of its own

## Indications for use
The ANKYLOS® C/X Dental Implant System is for single-stage or two-stage surgical procedures and cemented or screw retained restorations. The ANKYLOS® C/X Dental Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.

Source page: https://510kreport.com/device/K083805
Methodology: https://510kreport.com/methodology