# K141188: Microdent Genius Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Implant Microdent
- Decided: Jun 2, 2015 after 390 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: 8 generations back to K894595 (1990). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083805: Ankylos C/X Dental Implant System, Dentsply Intl., Inc. (2009) Summary page 4.
- K041509: Ankylos Dental Implant System, Friadent GmbH (2004) Summary page 4.
- K021318: Xive Dental Implant System, Friadent GmbH (2002) Summary page 4.

## Indications for use
Microdent Genius Implant System is indicated for surgical placement in the upper or lower jaw arches, for single-stage or two-stage surgical procedures and cemented, screw retained restorations or overdentures. Microdent Genius Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Small diameter implants are indicated only for replacement of central and lateral incisors in the maxillar and mandible.

Source page: https://510kreport.com/device/K141188
Methodology: https://510kreport.com/methodology