# K103790: Ace Trimark Tricam Dental Implant

- Pathway: 510(k) (Traditional)
- Applicant: Ace Surgical Supply Company, Inc.
- Decided: Aug 18, 2011 after 234 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: 4 generations back to K894595 (1990). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 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.
- K023113: Replace Tiunite Endosseous Implant, Nobel Biocare Uas, Inc. (2002) Summary page 1.

## Indications for use
The TriMark TriCam 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 TriMark TriCam 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 is intended for use with all standard straight abutment prosthetics and is not intended for use with angled abutments. The system can also be used for single tooth restorations. The TriMark TriCam Dental Implant System uses a two-stage implantation process and is not intended for immediate loading. The TriMark TriCam Dental Implant System is compatible with 0 (zero) degree, straight version of the Atlantis Abutment for Nobel Replace Interface.

Source page: https://510kreport.com/device/K103790
Methodology: https://510kreport.com/methodology