MODIFICATION TO: LOCATOR IMPLANT ANCHOR— 510(k) K072878

Clearance details

Applicant

Zest Anchors, Inc.

Product code

Code NHA

Device class

Class 2

Regulation

21 CFR 872.3630

Advisory panel

Dental

Date received

2007-10-09

Decision date

2007-12-03

Decision

Substantially Equivalent

Clearance type

Special

Location

Escondido, CA, US

• K253999 — Universal Base ASC Engaging +6 more2026-08-06
• K261147 — Neodent Implant System - NeoConvert Fit2026-07-01
• K261122 — MIST IC2026-06-27
• K260061 — BioHorizons CEREC Compatible Ti-Bases2026-06-26
• K253922 — Neodent Scannable Healing Abutment2026-06-15

• K150295 — LOCATOR RTx2015-07-24
• K083324 — LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM2009-02-25
• 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
• K994257 — LOCATOR IMPLANT ANCHOR2000-03-17

Injury

1,270

Malfunction

2,860

Total

4,130

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 K072878.