# K031106: Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX

- Pathway: 510(k) (Traditional)
- Applicant: Imtec Corp.
- Decided: Aug 12, 2003 after 126 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
227 later devices descend from it; 23 cite it directly.
0 of 228 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K063364: Alpha Bio Dental Implant System (2007), 187 descendants of its own
- K070601: Mini Drive-Lock Dental Implant System (2007), 144 descendants of its own
- K081653: Mdi Mii One-Piece Implant, 2.9MM (2008), 141 descendants of its own
- K073343: Ace Surgical Secure-Mini Implant System, Model 09-270X-XX (2008), 135 descendants of its own
- K092594: Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX, 09-2703-OX, 09-2705-OX (2009), 134 descendants of its own

## Recalls of this device
- May 14, 2010 · Not classified · Z-1703-2010: Product has Incorrect size Labeling. Actual length is 13mm. One label is correct, and one states 10mm.

## Indications for use
The MDI and MDI PLUS are self-tapping titanium threaded screws indicated for long-term intra-bony applications. Additionally, the MDI may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full partial endentulism, and employing minimally invasive surgical intervention.

Source page: https://510kreport.com/device/K031106
Methodology: https://510kreport.com/methodology