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Locator Angled Abutment

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250721

by Zest Anchors, LLC

Identifiers

510(k) Number
K250721 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 mechanism for overdenture systems, enabling improved stability and retention in 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. The angled design accommodates varying anatomical constraints, and it is compatible with standard implant systems for use in restoring masticatory function.

Frequently asked questions

What types of dental restorations can the LOCATOR® Angled Abutment be used with, and why is the angled design important?

The LOCATOR® Angled Abutment is designed for both removable and fixed restorations, particularly for overdenture systems. The angled design is crucial because it helps accommodate varying anatomical constraints in patients, ensuring a secure connection even when there are spatial limitations or irregularities in the jawbone. This improves stability and retention, which is essential for restoring masticatory function in edentulous patients.

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

The LOCATOR® Angled Abutment is explicitly intended for single-use in dental settings. This design choice ensures sterility and reduces the risk of cross-contamination or infection, which is critical in implant dentistry. Clinicians should treat it as a disposable component, replacing it after each procedure to maintain patient safety and compliance with sterile protocols.

How is the LOCATOR® Angled Abutment supplied, and what does its sterile packaging imply for clinical workflow?

The LOCATOR® Angled Abutment is supplied sterile, meaning it is pre-sterilized and packaged to prevent contamination before use. This eliminates the need for additional sterilization steps in the clinic, streamlining workflow and ensuring immediate readiness for implantation. Clinicians can rely on its sterility as a key factor in maintaining aseptic conditions during dental procedures.

What regulatory pathway did the LOCATOR® Angled Abutment follow to gain market authorization, and what does this mean for its safety and equivalence?

The device received FDA 510(k) clearance under the *Traditional* review pathway, classified under product code NHA (Dental). The decision was based on its determination as *Substantially Equivalent* (SESE) to a predicate device, meaning the FDA evaluated it against an existing, cleared product to confirm its safety and performance. This pathway ensures that the abutment meets established standards for dental implants while maintaining compliance with U.S. regulatory requirements.

Can the LOCATOR® Angled Abutment be used with standard dental implant systems, and what compatibility considerations should clinicians keep in mind?

Yes, the LOCATOR® Angled Abutment is compatible with standard implant systems, as noted in its design intent. However, clinicians should verify compatibility with the specific implant platform they are using, as variations in abutment interfaces or connection types may exist. The angled design is a key feature, so ensuring the implant’s platform can accommodate this angle—without compromising stability—is essential for successful restoration.

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) K250721 24 fields · synced Sep 18, 2026