# K111120: CSM Submerged-R Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Csm Implant
- Decided: Oct 14, 2011 after 176 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: 11 generations back to K960026 (1996). 46 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090825: SQ IS System, Neobiotech Co., Ltd. (2009) Summary page 2.
- K093321: Biohorizons Laser-Lok 3.0 Implant System, BioHorizons Implant Systems, Inc. (2010) Summary page 3.

## Most influential descendants
- K153350: IBS Implant System (2016), 7 descendants of its own
- K162099: IBS Implant System II (2017), 5 descendants of its own
- K173120: CCM Abutment System (2018), 3 descendants of its own
- K202418: Magic UCLA Abutment System (2020), 2 descendants of its own
- K212517: Magicore System (2021), 1 descendant of its own

## Indications for use
The CSM submerged-R Implant System is especially designed for use in dental implant surgery. According to the widely accepted clinical studies successful osseointegration between fixture and the live bone depends on surgical implantation under proper conditions, shape of fixture and surface treatment technique. Implants are intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. In case of Customized Hand Milling Abutment, its wall thickness is 2mm and height is 12mm. It can be reduced into Max. 7mm. The margin of the product can be modified up to Max 200. In case of Non-Hex Cementation Abutment, it is a bridge type. Two or more products must be used. Under part of abutment is made in round shape in order to avoid restriction in connecting work.

Source page: https://510kreport.com/device/K111120
Methodology: https://510kreport.com/methodology