# K132144: Kerator

- Pathway: 510(k) (Traditional)
- Applicant: LK Consulting Group USA, Inc.
- Decided: Mar 21, 2014 after 253 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). 56 ancestors in all.
No later device cites it as a predicate yet.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121047: Hero II Dental Implant System, IS Dental Implant System, Kj Meditech Co., Ltd. (2012) Summary page 1.
- K112787: Kerator, Kj Meditech Co., Ltd. (2012)
- K994257: Locator Implant Anchor, Zest Anchors, Inc. (2000) Summary page 1.

## Indications for use
The Kerator fixture is intended for use in partially or fully edentulous mandibles and maxillae, in support of multiple-unit restorations. The Kerator abutments are intended use with overdentures or partial dentures. Kerator AO type is compatible with Kerator fixture and the following types are compatible with the fixtures made by other manufacturers as indicated below.

Source page: https://510kreport.com/device/K132144
Methodology: https://510kreport.com/methodology