# K110548: Osi O-Ball Abutment Head Implants

- Pathway: 510(k) (Traditional)
- Applicant: Juell Dental
- Decided: Jul 29, 2011 after 154 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: 9 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)
- K102436: Nobel Active 3.0, Nobel Biocare AB (2010) Summary page 1.
- K091182: Champions Implants GMBH Mimi 1-Piece Precision Implant, Model 1000 UP to 6000, Champions Implants GmbH (2010) Summary page 1.

## Most influential descendants
- K213576: Tatum Surgical Dental Implant System (2022), 1 descendant of its own
- K254145: Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) (2026), 0 descendants of its own

## Indications for use
The 051 0-ball Abutment implant is a self-tapping titanium threaded screw indicated for long term intra-bony fixation of upper and lower dentures in edentulous cases. These devices will permit immediate splinting and ability and short-term fixation of failing crown and bridge installations, for full or partial edentulism. They can be used in the anterior regions of the maxillary and mandibular arches and are indicated for immediate loading when there is good primary stability and appropriate occlusal load.

Source page: https://510kreport.com/device/K110548
Methodology: https://510kreport.com/methodology