# K251515: Solidex® Ti-Links and Screws

- Pathway: 510(k) (Traditional)
- Applicant: CreoDent Hudson Valley
- Decided: Feb 10, 2026 after 270 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: 21 generations back to K960026 (1996). 326 ancestors in all.
No later device cites it as a predicate yet.
0 of 327 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240982: DESS Dental Smart Solutions, Terrats Medical SL (2024) Summary page 5.

## Indications for use
Solidex® Ti-Links and Screws is intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. All digitally designed custom abutments for use with Solidex® Ti-Links is to be sent to a CREODENT HUDSON VALLEY validated milling center for manufacture, or to be designed and manufactured according to the digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine, and associated tooling and accessories.

Source page: https://510kreport.com/device/K251515
Methodology: https://510kreport.com/methodology