LOCATOR® Angled Abutment— 510(k) K260555

Substantially Equivalent

Zest Anchors, LLC

FDA 510(k) clearance K260555 for LOCATOR® Angled Abutment, Substantially Equivalent on 2026-04-09. Applicant: Zest Anchors, LLC. Device class: 2.

Summary

The LOCATOR Angled Abutment is a dental implant abutment from Zest Anchors, filed under NHA, endosseous dental implant abutments. The code covers abutments used with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

Class II, 21 CFR 872.3630. The Dental panel reviewed it as a Special 510(k).

Zest Anchors filed from Carlsbad, California. Review took 50 days (February 18 to April 9, 2026).

Clearance details

Applicant
Zest Anchors, LLC
Product code
Product code NHA
Device class
Class 2
Regulation
21 CFR 872.3630
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Carlsbad, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code NHA

product code NHA
Injury
1,270
Malfunction
2,860
Total
4,130

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.