# K123491: Biodenta Dental Implant System - Multi-Use Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Biodenta Swiss AG
- Decided: May 30, 2013 after 198 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- 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 K894595 (1990). 54 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 66 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.
- K072570: Nobelactive Multi Unit Abutment, Nobel Biocare AB (2007) Summary page 1.
- K092341: Low Profile Abutments - Internal and External Connection, Biomet 3i, Inc. (2009) Summary page 2.

## Most influential descendants
- 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
- K231827: BTI Dental Implant System UnicCa® – Aesthetic Post Abutments (2023), 2 descendants of its own
- K151295: Biodenta Customized Abutment - Titanium (2015), 1 descendant of its own

## Indications for use
Biodenta Dental Implant System Multi-Use Abutments are intended for terminal or intermediate abutment support for fixed or removable crown, bridgework and to retain overdentures.

Source page: https://510kreport.com/device/K123491
Methodology: https://510kreport.com/methodology