# K202095: CreoDent Solidex Customized Abutment and Screw

- Pathway: 510(k) (Traditional)
- Applicant: Creodent Prosthetics, Ltd.
- Decided: Dec 16, 2020 after 140 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: 13 generations back to K894595 (1990). 130 ancestors in all.
No later device cites it as a predicate yet.
0 of 131 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.
- K171784: Straumann Dental Implant System, Straumann USA, LLC (2018) Summary page 6.

## Indications for use
The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. 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 and Screw are compatible with the following: Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5

Source page: https://510kreport.com/device/K202095
Methodology: https://510kreport.com/methodology