LOCATOR OVERDENTURE IMPLANT SYSTEM— 510(k) K120198

Name: FDA 510(k) clearance K120198
Creator: U.S. Food and Drug Administration
Published: 2012-06-06

Substantially Equivalent

Zest Anchors, LLC

FDA 510(k) clearance K120198 for LOCATOR OVERDENTURE IMPLANT SYSTEM, Substantially Equivalent on 2012-06-06. Applicant: Zest Anchors, LLC. Device class: 2.

Clearance details

Applicant: Zest Anchors, LLC
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2012-01-23
Decision date: 2012-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Escondido, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZE

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K260463 — ZEROS Dental Implant System2026-08-19
K251188 — UNIQA® Dental Implants System2026-06-25
K250806 — Dental Implant System2026-06-18
K251232 — MegaGen Zygoma Dental Implant System2026-06-18
K260006 — INOSS System2026-06-17

More clearances from Zest Anchors, LLC

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K260555 — LOCATOR® Angled Abutment2026-04-09
K252944 — LOCATOR® Angled Abutment2025-10-15
K250721 — LOCATOR® Angled Abutment2025-08-20
K243272 — LOCATOR Angled Abutment2025-01-14
K233587 — LOCATOR Angled Abutment (Various)2024-06-03

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K120198

K-number listed on FDA's recall record

Z-2425-2020 — LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .Class II·Ongoing·Zest Anchors LLC·20191122

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120198.

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