# K071638: Biohorizons Tapered Internal Implant System

- Pathway: 510(k) (Traditional)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Oct 10, 2007 after 117 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
129 later devices descend from it; 12 cite it directly.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K073268: Biohorizons Internal Implant System (2008), 111 descendants of its own
- K093321: Biohorizons Laser-Lok 3.0 Implant System (2010), 103 descendants of its own
- K073282: Biohorizons Single-Stage Implant System (2008), 76 descendants of its own
- K100985: Biohorizons Simple Solutions with Laser-Lok (2010), 73 descendants of its own
- K103691: Biohorizons Abutments for Zimmer (2011), 45 descendants of its own

## Recalls of this device
- Dec 6, 2024 · Class II · Z-1111-2025: Certain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment, which may lead the titanium abutment fractur
- Apr 16, 2015 · Class II · Z-1605-2015: BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium.

## Indications for use
The BioHorizons Tapered Internal Implant System is intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The BioHorizons Tapered Internal Implant System 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/K071638
Methodology: https://510kreport.com/methodology