# K150012: CreoDent Solidex Customized Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Creodent Prosthetics, Ltd.
- Decided: Jun 4, 2015 after 150 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: 10 generations back to K894595 (1990). 77 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113738: Creodent Solidex Custom Abutment, Creodent Prosthetics, Ltd. (2013) Summary page 5.

## Most influential descendants
- K162734: CreoDent Solidex Customized Abutment (2017), 1 descendant of its own
- K220390: CreoDent Solidex Customized Abutment and Screw (2022), 0 descendants of its own
- K202909: CreoDent Solidex Customized Abutment (2021), 0 descendants of its own
- K202095: CreoDent Solidex Customized Abutment and Screw (2020), 0 descendants of its own
- K170100: CreoDent Solidex Customized Abutment and Screw (2017), 0 descendants of its own

## Indications for use
The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for single or multiple-unit 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. The CreoDent Solidex® Customized Abutment is compatible with the following: Biomet 3i Osseotite Certain Dental Implants 3.25mm, 4.0mm, 5.0mm, 6.0mm Straumann Bone Level Implants 3.3mm, 4.1mm, 4.8mm

Source page: https://510kreport.com/device/K150012
Methodology: https://510kreport.com/methodology