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Locator Angled Abutment

FDA 510(k)

Class II (US FDA 510(k))

510(k) K243272

by Zest Anchors, LLC

Identifiers

510(k) Number
K243272 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 removable or fixed restorations to endosseous implants. It provides a secure connection for overdentures, partial dentures, or fixed prosthetics, enabling improved stability and retention in edentulous patients.

This device is supplied sterile and intended for single-use, adhering to FDA 510(k) clearance under product code NHA. It is used in dental settings for implant-supported restorations and must be handled with sterile techniques. The angled design accommodates specific anatomical or prosthetic requirements, ensuring compatibility with standard implant platforms.

Frequently asked questions

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

The LOCATOR Angled Abutment is designed to securely attach removable overdentures, partial dentures, or fixed prosthetics to dental implants. The angled design accommodates specific anatomical or prosthetic requirements, ensuring better alignment and stability for the restoration. This is particularly useful in cases where standard straight abutments may not fit due to patient anatomy or prosthetic design constraints.

Is the LOCATOR Angled Abutment intended for reuse, or is it meant to be used only once? How does this affect clinical handling?

The LOCATOR Angled Abutment is explicitly intended for single-use only, as stated in the device description. This means it must be handled with strict sterile techniques during and after use, similar to other single-use dental implants. Reuse could compromise sterility and patient safety, so proper disposal after one use is required.

How is the LOCATOR Angled Abutment supplied, and what should clinicians consider when storing it?

The device is supplied sterile, ensuring it is ready for immediate clinical use without additional sterilization. Since it is single-use, storage should follow standard sterile packaging protocols—keep it in a clean, dry environment away from direct sunlight or extreme temperatures. Unopened packages should be stored according to manufacturer instructions to maintain sterility until use.

What is the regulatory pathway for the LOCATOR Angled Abutment, and how does this affect its use in dental practices?

The LOCATOR Angled Abutment received FDA 510(k) clearance under product code NHA, which categorizes it as a dental implant abutment. This clearance confirms it meets FDA standards for safety and effectiveness as a substantially equivalent device to predecessors. Clinicians can proceed with its use knowing it complies with U.S. regulatory requirements for dental implant components, though local state or facility protocols may still apply.

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

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) K243272 24 fields · synced Sep 18, 2026