DeviceClearance

K260555

Substantially Equivalent

LOCATOR® Angled Abutment

The LOCATOR Angled Abutment is a dental implant abutment — product code NHA covers endosseous dental implant components, specifically the abutment elements that connect the implanted fixture to the prosthetic restoration. Zest Anchors is the incumbent in the overdenture-retention niche; the LOCATOR line is their flagship.

Dental panel, Special 510(k) — modification to the existing LOCATOR platform, likely adding angulation options or material variants to the cleared line.

Zest Anchors, LLC files from Carlsbad, CA. Under-two-month review clock, typical for Special 510(k) on a mature dental-implant product family.

Applicant
Zest Anchors, LLC
Product code
NHA
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Carlsbad, CA, US
Download summary PDF View on FDA.gov ↗

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.