# K120198: Locator Overdenture Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Zest Anchors, LLC
- Decided: Jun 6, 2012 after 135 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K021045 (2002). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092594: Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX, 09-2703-OX, 09-2705-OX, Ace Surgical Supply Co., Inc. (2009) Summary page 1.

## Most influential descendants
- K203701: Locator Overdenture Implant System (2021), 0 descendants of its own
- K133327: Saturno (TM) Overdenture Implant System (2014), 0 descendants of its own

## Recalls of this device
- Nov 22, 2019 · Class II · Z-2425-2020: The abutment provided with the Implant System may be out of specification, which could lead to a small gap occurring between the implant and abutment on assembly in the patient.

## Indications for use
The LOCATOR® Overdenture Implant System is designed to retain overdentures or partial dentures in the mandible or maxilia.

Source page: https://510kreport.com/device/K120198
Methodology: https://510kreport.com/methodology