# K151295: Biodenta Customized Abutment - Titanium

- Pathway: 510(k) (Traditional)
- Applicant: Biodenta Swiss AG
- Decided: Dec 1, 2015 after 200 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: 12 generations back to K960026 (1996). 215 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 217 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110778: Biodenta Customized Abutment, Biodenta Swiss AG (2011) Summary page 4.
- K100993: Inclusive Titanium Abutments for Astra Tech Osseospeed Implants, Prismatik Dentalcraft, Inc. (2010) Summary page 4.
- K142118: Inclusive Titanium Abutments Compatible with: Straumann Bone Level, Nobel Biocare Branae, Prismatik Dentalcraft, Inc. (2014) Summary page 5.
- K142115: Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare Implant, Prismatik Dentalcraft, Inc. (2014) Summary page 5.
- K123491: Biodenta Dental Implant System - Multi-Use Abutment, Biodenta Swiss AG (2013) Summary page 5.

## Most influential descendants
- K231210: DGA Abutment (2024), 0 descendants of its own

## Indications for use
The Biodenta Customized Abutment - Titanium is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. The Biodenta Customized Abutment - Titanium is compatible with the following dental implant systems:

Source page: https://510kreport.com/device/K151295
Methodology: https://510kreport.com/methodology