# K143022: BioHorizons Tapered Internal Implants

- Pathway: 510(k) (Special)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Jan 8, 2015 after 79 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- 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). 21 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071638: Biohorizons Tapered Internal Implant System, BioHorizons Implant Systems, Inc. (2007) Summary page 4.
- K093321: Biohorizons Laser-Lok 3.0 Implant System, BioHorizons Implant Systems, Inc. (2010) Summary page 4.

## Most influential descendants
- K240187: Tapered Pro Conical Implant System (2024), 2 descendants of its own
- K260061: BioHorizons CEREC Compatible Ti-Bases (2026), 0 descendants of its own
- K243521: Conical Ti Base abutments (2025), 0 descendants of its own
- K170211: Insight Dental System (2017), 0 descendants of its own

## Indications for use
BioHorizons Tapered Internal Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

Source page: https://510kreport.com/device/K143022
Methodology: https://510kreport.com/methodology