# K192614: Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Megagen Implant Co., Ltd.
- Decided: Feb 13, 2020 after 143 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: 15 generations back to K894595 (1990). 232 ancestors in all.
No later device cites it as a predicate yet.
0 of 233 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182091: Osstem Abutment System, Osstem Implant Co., Ltd. (2019) Summary page 4.
- K162867: MagDen Dental Implant System, Shinhung Mst Co., Ltd. (2017) Summary page 4.

## Indications for use
The Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. Intended for fully edentulous jaw retaining a tissue supported overdenture. The abutments in combination with endosseous implants are used as the foundation for anchoring tooth replacements in either jaw. The attachments are used in fixed overdenture restorations that can be attached with a snap-in system.

Source page: https://510kreport.com/device/K192614
Methodology: https://510kreport.com/methodology