# K990983: Modification to Imtec Sendax Mdi

- Pathway: 510(k) (Special)
- Applicant: Imtec Corp.
- Decided: Apr 13, 1999 after 20 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.
316 later devices descend from it; 3 cite it directly.
0 of 317 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 intra-bony and inter-radicular transitional application, to permit immediate splinting stability and ongoing fixation of new or existing crown and bridge instillations, for full or partial edentulism, an employing minimally invasive surgical intervention. Representative applications include the following: * Temporary (transitional supports for fixed or removable implant-supported prosthesies while conventional implants are integrating. * Stabilizing interim prostheses in graft sites and guided tissue regeneration applications to avoid iatrogenic damage to healing grafts, membranes or integrating implants. * Introductory system for nervous or apprehensive potential patients, offering a simple methodology for testing out the actual "feel of bone anchored implants, without the major commitment to final restorations; or as an interim system for medical 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/K990983
Methodology: https://510kreport.com/methodology