# K123415: Biodenta Dental Implant System- Bone Level Tapered

- Pathway: 510(k) (Traditional)
- Applicant: Biodenta Swiss AG
- Decided: Mar 19, 2013 after 134 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: 11 generations back to K960026 (1996). 126 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111003: Biodenta Dental Implant System - Bone Level, Biodenta Swiss AG (2011) Summary page 1.
- K101545: Genesis Implant System, Keystone Dental (2010) Summary page 1.

## Most influential descendants
- K133884: Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MM (2014), 1 descendant of its own
- K141159: Konus Dental Implant System (2015), 0 descendants of its own

## Indications for use
Biodenta bone level tapered dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures.

Source page: https://510kreport.com/device/K123415
Methodology: https://510kreport.com/methodology