# K220390: CreoDent Solidex Customized Abutment and Screw

- Pathway: 510(k) (Traditional)
- Applicant: Creodent Prosthetics, Ltd.
- Decided: Dec 2, 2022 after 294 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.
No later device cites it as a predicate yet.
0 of 79 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.

## 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. CreoDent Solidex Customized Abutments and Screws to be compatible with the Implant Direct InterActive/Swish Active 3.0mm implants are only indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

Source page: https://510kreport.com/device/K220390
Methodology: https://510kreport.com/methodology