# K101890: Ball Abutment System

- Pathway: 510(k) (Traditional)
- Applicant: Megagen Co., Ltd.
- Decided: Feb 3, 2011 after 211 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: 7 generations back to K894595 (1990). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063861: GS System, Osstem Implant Co., Ltd. (2007)
- K051636: Camlog Dental Implant Abutments, Healing Caps, and Accessories, Altatec GmbH (2006) Summary page 3.

## Indications for use
The Ball Abutment Systems are used for implant retained mucosa-supported restorations, such as overdentures where the patient is fully edentulous in the arch to be restored. There are two types of Ball Abutment system, internal and external type, and the ball abutment technique is used on Ball Abutment System implants in the maxilla or mandible.

Source page: https://510kreport.com/device/K101890
Methodology: https://510kreport.com/methodology