# K102635: Apolonia Laser Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Csm Implant Co., Ltd.
- Decided: Mar 22, 2011 after 190 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 K960026 (1996). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073268: Biohorizons Internal Implant System, BioHorizons Implant Systems, Inc. (2008) Summary page 1.

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

## Indications for use
CSM Implants are 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/K102635
Methodology: https://510kreport.com/methodology