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Locator Angled Abutment

FDA 510(k)

Class II (US FDA 510(k))

510(k) K252944

by Zest Anchors, LLC

Identifiers

510(k) Number
K252944 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 Angled Abutment is a dental implant abutment designed for the attachment of overdenture restorations. It provides a secure connection for removable or fixed prosthetics retained by endosseous implants, facilitating masticatory function in edentulous patients.

This device is intended for use in dental settings and is supplied sterile for single-use. It is classified under product code NHA and has received FDA 510(k) clearance as substantially equivalent to a predicate device. The angled design accommodates varying implant positions, ensuring adaptability for clinical applications.

Frequently asked questions

What types of dental prosthetics can the LOCATOR® Angled Abutment support, and why is the angled design important?

The LOCATOR® Angled Abutment is designed to securely attach both removable and fixed overdenture restorations, helping patients regain functional chewing (masticatory) ability after tooth loss. The angled design is crucial because it accommodates variations in implant positioning, ensuring a stable fit even when implants aren’t perfectly aligned. This adaptability improves the likelihood of a successful prosthetic attachment in complex cases.

Is the LOCATOR® Angled Abutment meant for reuse, or is it intended for single-use only?

The LOCATOR® Angled Abutment is supplied sterile and explicitly intended for single-use only. This ensures patient safety and sterility, as reuse could compromise hygiene and integrity, particularly in dental applications where infection control is critical.

How should the LOCATOR® Angled Abutment be stored, and what precautions should be taken before use?

Since the device is sterile upon delivery, it should be stored in its original packaging until ready for use to maintain sterility. The packaging should remain unopened and protected from contamination, moisture, or physical damage. Always check the expiration date and integrity of the seal before opening to ensure the device remains safe for clinical application.

What distinguishes the FDA clearance process for this device, and what does ‘substantially equivalent’ mean in this context?

The LOCATOR® Angled Abutment received FDA 510(k) clearance under the Special clearance type, classified under product code NHA (Dental Abutments). The term *‘substantially equivalent’* means the FDA determined it has the same intended use and technological characteristics as a legally marketed predicate device, ensuring it meets safety and effectiveness standards without requiring a full premarket approval process.

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 Angled Abutments | Zest Dental Solutions, PDF LOCATOR® ANGLED ABUTMENT - Amazon Web Services, LOCATOR® Angled Abutment by Zest Anchors, LLC | FDA 510 (k) Summary

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Zest Anchors, LLC

Sources (1)

  • FDA 510(k) K252944 24 fields · synced Sep 18, 2026