← Back to catalogue

Locator Angled Abutment

FDA 510(k)

Class II (US FDA 510(k))

510(k) K233587

by Zest Anchors, LLC

Identifiers

510(k) Number
K233587 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 use in overdenture systems. It provides an angled connection interface to facilitate attachment of removable dental prostheses, accommodating varying patient anatomies and improving stability for edentulous patients.

This device is supplied sterile and intended for single-use in dental settings. It is classified under product code NHA and has received FDA 510(k) clearance as substantially equivalent to a predicate device. Available in various configurations, it is regulated under dental implant standards and must be handled according to aseptic protocols.

Frequently asked questions

What types of dental prostheses is the LOCATOR Angled Abutment designed to support, and why is the angled design important?

The LOCATOR Angled Abutment is specifically designed for overdenture systems, which are removable dental prostheses used by edentulous patients. The angled design accommodates variations in patient anatomy, particularly when natural or implant-supported teeth are misaligned or when the patient’s jaw structure requires an offset connection. This angled interface improves stability and ensures a secure attachment of the overdenture, reducing the risk of loosening or discomfort during use.

Is the LOCATOR Angled Abutment reusable, or is it intended for single-use only? How should it be handled to maintain sterility?

The LOCATOR Angled Abutment is intended for single-use only and is supplied sterile. Since it is classified under dental implant standards, it must be handled using aseptic protocols to prevent contamination. This includes opening the sterile packaging only in a clean environment and ensuring no direct contact with unsterile surfaces before use.

What configurations or sizes are available for the LOCATOR Angled Abutment, and how does this variety benefit patients?

The LOCATOR Angled Abutment is available in various configurations to adapt to different clinical needs. While exact sizes or angles are not specified, the variability allows for customization based on patient anatomy, implant positioning, and prosthetic requirements. This flexibility ensures better fit, improved stability, and enhanced functionality for edentulous patients using overdentures.

How is the sterility of the LOCATOR Angled Abutment maintained during storage, and what storage conditions should be followed?

Since the device is supplied sterile, it should be stored in its original, unopened packaging to preserve sterility. The packaging should be kept in a clean, dry environment away from direct sunlight, extreme temperatures, or moisture. Avoiding contamination during storage ensures the abutment remains ready for single-use in dental procedures without compromising safety.

What regulatory pathway was followed for FDA clearance, and what does the product code NHA indicate about its classification?

The LOCATOR Angled Abutment received FDA 510(k) clearance under the Traditional Review pathway, with a decision code of SESE (Substantially Equivalent in Safety and Effectiveness). The product code NHA classifies it under dental implants, specifically for abutments and connectors, confirming its role in dental implant systems. This classification aligns with its use in overdenture 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 Angled Abutments | Zest Dental Solutions, Zest Locator Online Shop: Deutschland, Österreich, Schweiz, 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Zest Anchors, LLC

Sources (1)

  • FDA 510(k) K233587 24 fields · synced Sep 18, 2026