# K102981: Ace Freedom Internal Hexagon Dental Implant System

- Pathway: 510(k) (Special)
- Applicant: Ace Surgical Supply Company, Inc.
- Decided: Dec 20, 2010 after 74 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
Longest line of descent: 1 generation back to K954513 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954513: Ace Srew Dentla Implant System, Ace Surgical Supply Co., Inc. (1996) Summary page 1.
- K011028: Screw-Vent Dental Implant System, Sulzer Dental, Inc. (2001) Summary page 1.

## Indications for use
The iMARKTM Internal Hexagon Dental Implant System is used in indications for oral endosseous implants in the maxilla and/or mandible as part of a functional and aesthetic oral rehabilitation in partial or fully edentulous patients. The IMARK TM Internal Hexagon Dental Implant System is designed for use 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. The IMARK TM Internal Hexagon Dental Implant System uses a two-stage implantation process. The MARK TM Internal Hexagon Dental Implant System is compatible with Zimmer@ Tapered Screw Vent prosthetics.

Source page: https://510kreport.com/device/K102981
Methodology: https://510kreport.com/methodology