# K180998: BioHorizons CAD/CAM Bars

- Pathway: 510(k) (Traditional)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Sep 28, 2018 after 165 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: 7 generations back to K944964 (1995). 22 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080864: Cam Structsure Precision Milled Bars, Biomet 3i, Inc. (2008) Summary page 4.

## 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
- K260061: BioHorizons CEREC Compatible Ti-Bases (2026), 0 descendants of its own

## Indications for use
BioHorizons CAD/CAM Bars are intended for use as superstructures of a multiple-unit endosseous dental implant system, attaching directly to implants or abutments, to support a prosthetic device in a partially or fully endentulous patient for the purpose of restoring chewing function. Implant-level bars are compatible with all BioHorizons Internal and Tapered Internal implant systems. Implant-level bars are compatible with Zimmer Dental Screw-Vent® and Tapered Screw Vent® implants with 3.5mm, 4.5mm and 5.7mm internal hex connection mating platform diameters and are intended to be used with straight bar cylinders only. Abutment-level bars are compatible with BioHorizons Multi-unit Abutments. All digitally designed BioHorizons CAD/CAM Bars are intended to be sent to a BioHorizons-validated milling center for manufacture.

Source page: https://510kreport.com/device/K180998
Methodology: https://510kreport.com/methodology