Locator Overdenture Implant System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K120198 FDA 510(k)
- FDA Product Code
- DZE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Locator Overdenture Implant System is a dental implant attachment solution designed for overdentures, classified under the nomenclature category for dental implant abutments and attachments. It provides a secure, removable connection between implant fixtures and prosthetic overdentures, supporting both fully and partially edentulous patients with anatomical or functional limitations.
This system is supplied as a two-piece implant solution, featuring the Locator Attachment System in narrow or standard ridge diameters. It is intended for use in clinical settings by dental professionals, with components intended for single-use or as specified by the manufacturer. The system holds an FDA 510(k) clearance under the Traditional review pathway, with the product code DZE and advisory committee classification under Dental.
Frequently asked questions
What types of patients is the Locator Overdenture Implant System designed to support, and how does it differ from other dental implant attachments?
The Locator Overdenture Implant System is specifically designed for patients who are either fully or partially edentulous and face anatomical or functional challenges with traditional dentures. Unlike some other implant attachments, it provides a secure, removable connection between implant fixtures and overdentures, ensuring stability without requiring permanent fixation. This two-piece system is particularly useful for patients who need a balance of retention and ease of removal for maintenance or adjustments.
Is the Locator Overdenture Implant System available in different sizes, and how does that affect its use?
Yes, the system is supplied in two ridge diameters: narrow and standard. The choice between these sizes depends on the patient’s anatomical structure and the specific clinical requirements. Narrow diameters may be suitable for patients with limited ridge width, while standard diameters offer broader stability for patients with more available bone structure. The selection is made by the dental professional based on the patient’s individual needs and the implant placement.
How is the Locator Overdenture Implant System supplied, and what considerations should be made regarding its use in a clinical setting?
The system is supplied as a two-piece solution, consisting of the Locator Attachment System components. While the components are intended for single-use, the manufacturer may specify reuse conditions depending on clinical protocols and sterilization practices. In a clinical setting, dental professionals must follow the manufacturer’s instructions to ensure proper handling, sterilization (if reused), and compatibility with the patient’s specific overdenture design to maintain stability and hygiene.
What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for its use in the U.S.?
The Locator Overdenture Implant System received FDA clearance through the Traditional 510(k) review pathway, specifically under the product code DZE for dental implant abutments and attachments. This means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA standards for safety and effectiveness. Clinicians can rely on this clearance as confirmation that the system adheres to U.S. regulatory requirements for dental implant attachments.
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 Implant System | Zest Dental Solutions, Zest Locator Online Shop: Deutschland, Österreich, Schweiz, Locator Implant System | Zest Dental Solutions, PDF LOCATOR LO - zestdent-cms.s3.amazonaws.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120198 | Class II | Active |
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Manufacturer
- Manufacturer
- Zest Anchors, LLC
Sources (1)
- FDA 510(k) K120198 24 fields · synced Sep 18, 2026