# K081653: Mdi Mii One-Piece Implant, 2.9MM

- Pathway: 510(k) (Traditional)
- Applicant: Imtec Corp.
- Decided: Sep 19, 2008 after 99 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
Longest line of descent: 10 generations back to K960026 (1996). 78 ancestors in all.
141 later devices descend from it; 8 cite it directly.
0 of 220 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063364: Alpha Bio Dental Implant System, Alpha-Bio Tec, Ltd. (2007) Summary page 1.
- K052997: Zimmer Dental One-Piece Implant, Zimmer Dental, Inc. (2006) Summary page 1.
- K031106: Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX, Imtec Corp. (2003) Summary page 1.
- K030243: Endure Implant, Model 3508,3511,3514,4308,4311,4314, Imtec Corp. (2003) Summary page 1.

## Most influential descendants
- K123022: Neodent Implant System (2013), 127 descendants of its own
- K133510: Neodent Implant System (2014), 123 descendants of its own
- K133592: Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua and Drive Smart Acqua, Titamax CM (2014), 109 descendants of its own
- K150367: Neodent Implant System (2015), 89 descendants of its own
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own

## Recalls of this device
- Jul 7, 2009 · Not classified · Z-1997-2009: Size printed on product packaging does not match size of enclosed product.

## Indications for use
The M11 Implant is intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches. The MII implant is indicated for immediate loading when good primary stability is achieved. Additionally, this device will permit stability and long term fixation of upper and lower dentures in edentulous cases.

Source page: https://510kreport.com/device/K081653
Methodology: https://510kreport.com/methodology