# K182070: BioHorizons Tapered IM Implants

- Pathway: 510(k) (Special)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Oct 10, 2018 after 70 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: 2 generations back to K071638 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121787: Biohorizons Tapered Internal Plus Implants, BioHorizons Implant Systems, Inc. (2012) Summary page 4.

## Indications for use
BioHorizons Tapered IM 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/K182070
Methodology: https://510kreport.com/methodology