# K123512: Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MM

- Pathway: 510(k) (Traditional)
- Applicant: Biodenta Swiss AG
- Decided: Mar 28, 2013 after 135 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). 129 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 132 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.
- K102436: Nobel Active 3.0, Nobel Biocare AB (2010) Summary page 1.
- K103089: Seven Implants; Biocom Implants; Lance Implants, Mis - Implant Technologies, Ltd. (2011) Summary page 2.
- K101545: Genesis Implant System, Keystone Dental (2010) Summary page 2.

## 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 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/K123512
Methodology: https://510kreport.com/methodology