# K241183: ISO Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Seum Medi Co., Ltd.
- Decided: Jul 28, 2025 after 455 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: 8 generations back to K894595 (1990). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112787: Kerator, Kj Meditech Co., Ltd. (2012) Summary page 6.

## Indications for use
The ISO Abutment is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla. The ISO Abutment is compatible with the following fixtures.

Source page: https://510kreport.com/device/K241183
Methodology: https://510kreport.com/methodology