# K042429: The Prodigy System Dental Implants

- Pathway: 510(k) (Special)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Sep 16, 2004 after 8 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: 7 generations back to K960026 (1996). 9 ancestors in all.
120 later devices descend from it; 6 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)
- K960026: Biohorizons Dental Implant System, BioHorizons Implant Systems, Inc. (1996) Summary page 1.
- K010458: The Maestro System, BioHorizons Implant Systems, Inc. (2001) Summary page 1.
- K020133: Modification to the Maestro System, BioHorizons Implant Systems, Inc. (2002) Summary page 1.
- K030463: Modification to the Maestro System, BioHorizons Implant Systems, Inc. (2003) Summary page 1.

## 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
- K053152: Biohorizons Single-Stage Implant (2005), 77 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

## Indications for use
The Prodigy System endosseous implants may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and dental retention.

Source page: https://510kreport.com/device/K042429
Methodology: https://510kreport.com/methodology