# K173141: CSM Submerged3-L Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Csm Implant
- Decided: Sep 19, 2018 after 355 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: 10 generations back to K960026 (1996). 112 ancestors in all.
No later device cites it as a predicate yet.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102635: Apolonia Laser Implant System, Csm Implant Co., Ltd. (2011) Summary page 4.
- K120043: CSM Internal-R Implant System, Csm Implant (2012) Summary page 4.
- K081575: HU/HS/HG Prosthetic System, Osstem Implant Co., Ltd. (2008) Summary page 4.
- K112787: Kerator, Kj Meditech Co., Ltd. (2012) Summary page 4.

## Indications for use
The CSM Submerged3-L Implant System is intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. This system is intended for delayed loading.

Source page: https://510kreport.com/device/K173141
Methodology: https://510kreport.com/methodology