# K140347: Ankylos C/X Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl., Inc.
- Decided: Aug 20, 2014 after 190 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: 8 generations back to K894595 (1990). 22 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083805: Ankylos C/X Dental Implant System, Dentsply Intl., Inc. (2009) Summary page 4.
- K092035: Bicon Implants with a 2.5MM Internal Connection, Bicon, LLC (2009) Summary page 4.

## Most influential descendants
- K172505: MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments (2017), 4 descendants of its own
- K241692: MIS LYNX Conical Connection Implant System (2024), 2 descendants of its own
- K251647: MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System (2025), 0 descendants of its own
- K251297: MIS LYNX Conical Connection Implant System (2025), 0 descendants of its own
- K183079: Conometric Abutments (2019), 0 descendants of its own

## Indications for use
ANKYLOS® C/X lmplants of 8 mm in length or longer are for single-stage or two-stage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X lmplants may be used for immediate placement and function on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted. ANKYLOS® C/X lmplants of 6.6 mm in length are for two-stage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X lmplants may be used for immediate placement on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted.

Source page: https://510kreport.com/device/K140347
Methodology: https://510kreport.com/methodology