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Solidex Ti-Links and Screws

FDA 510(k)

Class II (US FDA 510(k))

510(k) K251515

by Creodent Hudson Valley

Identifiers

510(k) Number
K251515 FDA 510(k)
FDA Product Code
NHA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3630 FDA 510(k)
Regulation Number
872.3630 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Solidex Ti-Links and Screws are dental components intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. These devices are part of a system that includes digitally designed custom abutments.

All digitally designed custom abutments for use with Solidex Ti-Links must be sent to a CREODENT HUDSON VALLEY validated milling center for manufacture or designed and manufactured according to scanners, CAD software, and CAM software. The device is authorized under FDA 510K clearance with product code NHA and is intended for dental applications.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Creodent Hudson Valley 1769 Rt 52 Re: K251515 Trade/Device Name ..., PDF Creodent Ti-Link Instructions for Use, PDF Creodent Ti-Link Instructions for Use

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Creodent Hudson Valley

Sources (1)

  • FDA 510(k) K251515 24 fields · synced Sep 28, 2026