Cleared Traditional

Solidex? Ti-Links and Screws

K251515 · CreoDent Hudson Valley · Dental

Feb 2026

Decision

270d

Days

Class 2

Risk

About This 510(k) Submission

K251515 is an FDA 510(k) clearance for the Solidex? Ti-Links and Screws, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by CreoDent Hudson Valley (Fishkill, US). The FDA issued a Cleared decision on February 10, 2026, 270 days after receiving the submission on May 16, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K251515 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 2025
Decision Date	February 10, 2026
Days to Decision	270 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NHA — Abutment, Implant, Dental, Endosseous
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3630
Definition	To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.