# K241032: BellaTek Bars

- Pathway: 510(k) (Traditional)
- Applicant: Biomet 3i, LLC
- Decided: Jul 15, 2024 after 90 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 K944964 (1995). 67 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233083: Osteon Precision Milled Suprastructure, Implant Solutions Pty Ltd (Aka Osteon Medical) (2024) Summary page 5.

## Most influential descendants
- K260940: BellaTek Bars (2026), 0 descendants of its own

## Indications for use
The BellaTek Bars are indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The BellaTek Bars are intended for attachment to a minimum of two (2) abutments. All digitally designed BellaTek Bars are intended to be sent to Biomet 3i for manufacture. The BellaTek Bars are indicated for compatibility with the following abutment systems: * Universal Multi-Unit Abutments manufactured by Terrats Medical SL., 2.9-5.7mm, Angled, max 30 degrees * ZimVie Eztetic Implant System * ZimVie TSX Implant System * ZimVie Tapered Screw-Vent System * ZimVie Low Profile Abutments, 3.4-6.0mm, Angled, max 30 degrees * ZimVie Osseotite Implant System * ZimVie T3 and T3 PRO Implant System * ZimVie Tapered Abutments, 3.5-5.7mm, Angled, max 30 degrees * ZimVie TSX Implant System * ZimVie Tapered Screw-Vent Implant System

Source page: https://510kreport.com/device/K241032
Methodology: https://510kreport.com/methodology