# K972351: Sendax Mdi (Mini Dental Implant)

- Pathway: 510(k) (Traditional)
- Applicant: Sendax Mdic Management, Inc.
- Decided: Nov 24, 1997 after 153 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.
548 later devices descend from it; 8 cite it directly.
0 of 549 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 its predicate without a number.
- (no number) Dentatus MTI® Anchor Post/Modular Transitional Implant: named in the summary without a submission number

## Most influential descendants
- K980620: Dentatus Mti  Modular Transitional Implants and Prosthetic System (1998), 322 descendants of its own
- K030614: 3I Dental Implants (2003), 319 descendants of its own
- K041402: Modification to Osseotite NT Certain Implants (2004), 318 descendants of its own
- K051189: Prevail Dental Implants (2005), 317 descendants of its own
- K032351: The Maestro System 3.0MM Diameter Implant (2003), 313 descendants of its own

## Indications for use
This device is a self-tapping titanium threaded screw indicated for intra-bony and inter-radicular transitional applications, to permit immediate splinting stability and ongoing fixation of new or existing crown & bridge installations, for full or partial edentulism, and employing minimally invasive surgical intervention. Representative applications include the following: * Temporary (transitional) supports for fixed or removable implant-supported prostheses 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 * Introductory system for nervous or apprehensive potential implant 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 medically compromised, handicapped or terminally ill patients to enhance their comfort by maintaining a reasonable level of speech, mastication & general well-being, at modest cost levels.

Source page: https://510kreport.com/device/K972351
Methodology: https://510kreport.com/methodology