# K142751: Chang Gung ComMed Series Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Chang Gung Medical Technology Co., Ltd.
- Decided: Jun 15, 2015 after 264 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: 7 generations back to K894595 (1990). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033984: Straumann Dental Implant System, Institut Straumann AG (2004) Summary page 12.

## Indications for use
"ComMed" Series Dental Implant System is intended for surgical placement in the maxilla or mandible to provide for prosthetic attachment to restore a patient's chewing function. "ComMed" Series Dental Implants are intended only for delayed loading.

Source page: https://510kreport.com/device/K142751
Methodology: https://510kreport.com/methodology