# K243521: Conical Ti Base abutments

- Pathway: 510(k) (Traditional)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: May 1, 2025 after 169 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: 19 generations back to K894844 (1990). 327 ancestors in all.
No later device cites it as a predicate yet.
0 of 328 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240187: Tapered Pro Conical Implant System, BioHorizons Implant Systems, Inc. (2024) Summary page 5.
- K231307: Elos Accurate Customized Abutment, Elos Medtech Pinol A/S (2023) Summary page 5.

## Indications for use
BioHorizons conical dental prosthetic components connected to the endosseous dental implants are intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations. All digitally designed abutments for use with Conical Ti Base abutments are to be sent to a BioHorizons validated milling center for manufacture or to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.

Source page: https://510kreport.com/device/K243521
Methodology: https://510kreport.com/methodology