# K122268: Angled Xive MP Abutment, Angled Ankylos

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International
- Decided: Dec 11, 2012 after 134 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- 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). 25 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050406: Nobelspeedy Implants, Nobel Biocare AB (2005) Summary page 1.
- K073075: Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant Systems, Dentsply International, Inc. (2008) Summary page 1.
- K994174: Frialit-2 MH-2 Abutment, Friadent GmbH (2000) Summary page 1.

## Most influential descendants
- K131644: Ankylos Syncone Abutment 5(Degree) (2014), 1 descendant of its own
- K151439: Atlantis Isus (2016), 0 descendants of its own

## Indications for use
The angled XiVE® MP and angled ANKYLOS® Balance Base Abutments are indicated for use in prosthetic restorations with XiVE® and ANKYLOS® implants, respectively, and bridges or bar overdentures using a minimum of 2 implants. In edentulous jaws, immediate loading is possible using a minimum of 4 implants. Implants may be tilted up to 45°. When used with angulations between 30 and 45° in edentulous arch, a minimum of four implants must be used and splinted. The straight FRIADENT® MP and straight ANKYLOS® Balance Base Abutments are indicated for use in prosthetic restorations with XiVE®, FRIALIT® and ANKYLOS® implants, respectively, and bridges or bar overdentures using a minimum of 2 implants. In edentulous jaws, immediate loading is possible using a minimum of 4 implants.

Source page: https://510kreport.com/device/K122268
Methodology: https://510kreport.com/methodology