# K023067: Imtec Sendax Mdi ORTHO6 and ORTHO8

- Pathway: 510(k) (Traditional)
- Applicant: Imtec Corp.
- Decided: Dec 3, 2002 after 78 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.
321 later devices descend from it; 5 cite it directly.
0 of 322 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K032351: The Maestro System 3.0MM Diameter Implant (2003), 313 descendants of its own
- K041938: Maximus OS (Overdenture System) (2004), 271 descendants of its own
- K063364: Alpha Bio Dental Implant System (2007), 187 descendants of its own
- K081653: Mdi Mii One-Piece Implant, 2.9MM (2008), 141 descendants of its own
- K123022: Neodent Implant System (2013), 127 descendants of its own

## Indications for use
This device is a self-tapping titanium threaded screw indicated for long-term intra-bony applications, or as an inter-radicular transitional application. This device will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial endentulism, and employment of minimally invasive surgical interventions. Representative applications include the following: o Temporary (transitional supports for fixed or removable implant-supported prosthesis while conventional implants are integrating.) o Stabilizing interim prostheses in graft sites and guided tissue regeneration applications to avoid iatrogenic damage to healing grafts, membranes or integrating implants. o Introductory system for nervous or apprehensive potential patients, offering a simple methodology for testing the actual “feel” of bone anchored implants, without a major commitment to final restorations. o As an interim system for medically compromised, handicapped or terminally ill patients to enhance their comfort by maintaining a reasonable level of speech, mastication and general well being, at modest cost levels.

Source page: https://510kreport.com/device/K023067
Methodology: https://510kreport.com/methodology