LOCATOR IMPLANT ANCHOR— 510(k) K994257

Clearance details

Applicant

Zest Anchors, Inc.

Product code

Code DZE

Device class

Class 2

Regulation

21 CFR 872.3640

Advisory panel

Dental

Date received

1999-12-16

Decision date

2000-03-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Escondido, CA, US

• 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

• K150295 — LOCATOR RTx2015-07-24
• K083324 — LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM2009-02-25
• K072878 — MODIFICATION TO: LOCATOR IMPLANT ANCHOR2007-12-03
• K042466 — X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE2004-11-24
• K033699 — LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 085862004-04-22

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 →

• Z-0935-2014 — LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878Class II·Terminated·Zest Anchors LLC·20140116

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K994257.