# K120043: CSM Internal-R Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Csm Implant
- Decided: Apr 27, 2012 after 113 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: 8 generations back to K944964 (1995). 61 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090527: Sinus Quick IT System, Neobiotech Co., Ltd. (2009) Summary page 2.
- K071148: Atlas Implant System, Cowellmedi Co., Ltd. (2008) Summary page 2.

## Most influential descendants
- K173141: CSM Submerged3-L Implant System (2018), 0 descendants of its own

## Indications for use
The CSM Internal-R Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or over denture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is intended for delayed loading.

Source page: https://510kreport.com/device/K120043
Methodology: https://510kreport.com/methodology