# K040807: Mis Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Mis - Implant Technologies, Ltd.
- Decided: Jun 9, 2004 after 72 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
Longest line of descent: 4 generations back to K925765 (1993). 29 ancestors in all.
218 later devices descend from it; 22 cite it directly.
0 of 248 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022009: 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants, Implant Innovations, Inc. (2002) Summary page 2.
- K022113: 3I Dental Implant Accessories, Implant Innovations, Inc. (2002) Summary page 2.
- K030007: Iti Dental Implant System, Straumann USA (2003) Summary page 2.

## Most influential descendants
- 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
- 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

## Indications for use
The MIS Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

Source page: https://510kreport.com/device/K040807
Methodology: https://510kreport.com/methodology