# K162734: CreoDent Solidex Customized Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Creodent Prosthetics, Ltd.
- Decided: May 8, 2017 after 220 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- 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 K894595 (1990). 78 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150012: CreoDent Solidex Customized Abutment, Creodent Prosthetics, Ltd. (2015) Summary page 6.

## Most influential descendants
- K202909: CreoDent Solidex Customized Abutment (2021), 0 descendants of its own

## Indications for use
The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patents who are partially or completely edentulous. The device can be used for single or multiple restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.

Source page: https://510kreport.com/device/K162734
Methodology: https://510kreport.com/methodology