# K093630: Biodenta Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Biodenta Swiss AG
- Decided: Jun 3, 2010 after 192 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: 9 generations back to K894595 (1990). 46 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081419: Straumann Dental Implant System, Institut Straumann AG (2009) Summary page 1.
- K050705: Tiunite Implants, Nobel Biocare AB (2005) Summary page 2.

## Most influential descendants
- K111003: Biodenta Dental Implant System - Bone Level (2011), 17 descendants of its own
- K123491: Biodenta Dental Implant System - Multi-Use Abutment (2013), 11 descendants of its own
- K203252: Multi-unit Abutments for CONELOG (2021), 8 descendants of its own
- K213106: BTI Interna Dental Implant System UnicCa - Prosthetic Components (2022), 3 descendants of its own
- K240187: Tapered Pro Conical Implant System (2024), 2 descendants of its own

## Indications for use
Biodenta dental implants 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. Specific indications for small diameter (0 3.5 mm) implants: It is recommended not to place small implants with "NP" platform in the molar or premolar region.

Source page: https://510kreport.com/device/K093630
Methodology: https://510kreport.com/methodology