# K260940: BellaTek Bars

- Pathway: 510(k) (Special)
- Applicant: ZimVie US Corp, LLC
- Decided: Sep 21, 2026 after 185 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: 13 generations back to K944964 (1995). 68 ancestors in all.
No later device cites it as a predicate yet.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241032: BellaTek Bars, Biomet 3i, LLC (2024) Summary page 6.

## 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 ZimVie for manufacture. The BellaTek Bars are indicated for compatibility with the following abutment systems:  DESS NobelActive®/ NobelReplace® Multi-Unit Abutment Systems  DESS NobelActive®/ NobelReplace® MUA+ System  DESS Nobel Replace Select™ Multi-Unit Abutment Systems  DESS Nobel Brånemark Multi-Unit Abutment Systems  DESS ZimVie External Hex Multi-Unit Abutment Systems  DESS Straumann Bone Level Multi-Unit Abutment Systems  DESS Straumann Bone Level MUA+ System  DESS ZimVie Certain® Multi-Unit Abutment Systems  DESS Straumann BLX® Multi-Unit Abutment Systems  DESS Neodent Grand Morse (GM) Multi-Unit Abutment Systems  DESS Neodent Grand Morse (GM) MUA+ System  DESS ZimVie TSV® Multi-Unit Abutment Systems  DESS Astra Tech EV® Multi-Unit Abutment Systems  DESS Astra Tech Osseospeed Multi-Unit Abutment Systems  DESS Biohorizons Internal Hex Multi-Unit Abutment Systems  DESS Osstem® Multi-Unit Abutment Systems  DESS MIS Seven® Multi-Unit Abutment Systems  DESS Dentium Superline® & Implantium Multi-Unit Abutment Systems

Source page: https://510kreport.com/device/K260940
Methodology: https://510kreport.com/methodology