# K954513: Ace Srew Dentla Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Ace Surgical Supply Co., Inc.
- Decided: Jun 5, 1996 after 251 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K093518: Ace Surgical Secure Locator 3.25 Implant System (2010), 2 descendants of its own
- K131701: Z5MLB, Z5MLC (2013), 1 descendant of its own
- K041759: Ace Connect Internal Connection (2004), 1 descendant of its own
- K200386: Z5-BL (2020), 0 descendants of its own
- K103790: Ace Trimark Tricam Dental Implant (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K954513
Methodology: https://510kreport.com/methodology