# K093518: Ace Surgical Secure Locator 3.25 Implant System

- Pathway: 510(k) (Special)
- Applicant: Ace Surgical Supply Co., Inc.
- Decided: Jan 14, 2010 after 62 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). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 14 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.
- K954513: Ace Srew Dentla Implant System, Ace Surgical Supply Co., Inc. (1996) Summary page 1.

## Most influential descendants
- K131701: Z5MLB, Z5MLC (2013), 1 descendant of its own
- K200386: Z5-BL (2020), 0 descendants of its own

## Recalls of this device
- Feb 22, 2017 · Class II · Z-1835-2017: Incorrect device was packaged.

## Indications for use
The ACE Surgical Secure™ Locator® 3.25mm Implant System is designed to provide intra-bony long term fixation of denture installations in partially or fully edentulous patients.

Source page: https://510kreport.com/device/K093518
Methodology: https://510kreport.com/methodology