# K110778: Biodenta Customized Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Biodenta Swiss AG
- Decided: Jul 29, 2011 after 130 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 K960026 (1996). 127 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091026: TDS Abutment for Nobel Biocare Replace, Pou YU Biotechnology Co., Ltd. (2009) Summary page 1.
- K091392: TDS Titanium Abutment for Nobel Biocare Branemark, Pou YU Biotechnology Co., Ltd. (2009) Summary page 1.
- K032302: Xive TG Abutments, Friadent GmbH (2003) Summary page 1.
- K072241: Primaconnex Cad/Cam Abutment System, Lifecore Biomedical, Inc. (2007) Summary page 1.
- K063734: Atlantis Abutment in Zirconia for 3I Certain Interface, Atlantis Components, Inc. (2007) Summary page 1.

## Most influential descendants
- K151295: Biodenta Customized Abutment - Titanium (2015), 1 descendant of its own
- K231210: DGA Abutment (2024), 0 descendants of its own

## Indications for use
The Biodenta Customized Abutment 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 is compatible with the following implant systems: - Internal hex systems with flat-to-flat dimensions of 1.78mm or greater: Firadent: FRIALIT Implant, XiVA Implant; 3i: Certain Internal Connect Type; Astra: Osseospeed Implant, Osseospeed TX Implant; BioHorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System; Lifecore: Lifecore RENOVATM Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System. - Nobel Biocare Replace: NobelReplace Straight, NobelReplace Tapered; Replace Select Tapered, Replace Select Straight; for the NP, RP, WP and 6.0 implants. - External hex systems with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare Branemark, 3i, BioHorizons, and Lifecore.

Source page: https://510kreport.com/device/K110778
Methodology: https://510kreport.com/methodology