# K021244: Ace HA Screw Dental Implant System

- Pathway: 510(k) (Special)
- Applicant: Ace Surgical Supply Co., Inc.
- Decided: May 3, 2002 after 14 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K031322: Intra-Lock Hydroxyapatite Coated Implants (2003), 0 descendants of its own

## Indications for use
The Ace HA Screw Dental Implant System is intended to be used in totally edentulous mandibles or maxillae or as a terminal or intermediary abutment for fixed or removable bridgework. The system can also be used for single tooth restorations.

Source page: https://510kreport.com/device/K021244
Methodology: https://510kreport.com/methodology