LOCATOR F-Tx Attachment System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151789 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)
The LOCATOR F-Tx Attachment System is a dental implant attachment system used for overdentures. It is designed to provide a fixed attachment solution for dental prostheses.
This system is supplied by Zest Anchors, LLC and is available in various sizes. It is intended for use in dental applications and has received FDA 510K clearance and MDR authorization.
Frequently asked questions
What is the LOCATOR F-Tx Attachment System used for?
The LOCATOR F-Tx Attachment System is a dental implant attachment system designed specifically for overdentures, providing a fixed attachment solution for dental prostheses.
What sizes are available for the LOCATOR F-Tx Attachment System?
The system is available in various sizes to accommodate different dental applications, though specific size details are not provided in the device data.
Is the LOCATOR F-Tx Attachment System single-use or reusable?
The device data does not specify whether the LOCATOR F-Tx Attachment System is intended for single-use or reuse, so this information cannot be determined from the provided facts.
What regulatory approvals has the LOCATOR F-Tx Attachment System received?
The system has received FDA 510K clearance and MDR authorization, indicating it meets regulatory requirements for dental implant attachment systems.
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: LOCATOR F-Tx | Zest Dental Solutions | Zest Dental Solutions, Zest Locator Online Shop: Deutschland, Österreich, Schweiz, LOCATOR F-Tx® Fixed Attachment System: Rescue Solution - Zest Dent, LOCATOR F-Tx® Fixed Attachment System: Rescue Solution - Zest Dent
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K151789 | Class II | Active |
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Manufacturer
- Manufacturer
- Zest Anchors, LLC
Sources (2)
- FDA 510(k) K151789 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026