# K133884: Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MM

- Pathway: 510(k) (Traditional)
- Applicant: Biodenta Swiss AG
- Decided: Jun 13, 2014 after 175 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: 12 generations back to K960026 (1996). 131 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 133 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123512: Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MM, Biodenta Swiss AG (2013) Summary page 1.
- K123415: Biodenta Dental Implant System- Bone Level Tapered, Biodenta Swiss AG (2013) Summary page 1.
- K103089: Seven Implants; Biocom Implants; Lance Implants, Mis - Implant Technologies, Ltd. (2011) Summary page 2.

## Most influential descendants
- 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. They are intended for delayed loading.

Source page: https://510kreport.com/device/K133884
Methodology: https://510kreport.com/methodology