# K030463: Modification to the Maestro System

- Pathway: 510(k) (Special)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Feb 26, 2003 after 14 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K960026 (1996). 8 ancestors in all.
331 later devices descend from it; 2 cite it directly.
0 of 340 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.
- K964330: Biohorizons Dental Implant System (Name Subject to Change), BioHorizons Implant Systems, Inc. (1997) Summary page 1.
- K972313: The Maestro System, BioHorizons Implant Systems, Inc. (1997) Summary page 1.
- K010458: The Maestro System, BioHorizons Implant Systems, Inc. (2001)
- K020133: Modification to the Maestro System, BioHorizons Implant Systems, Inc. (2002) Summary page 1.
- K020645: Modification to the Maestro System, BioHorizons Implant Systems, Inc. (2002) Summary page 1.
- K022795: Modification to the Maestro System, BioHorizons Implant Systems, Inc. (2002) Summary page 1.

## Most influential descendants
- K032351: The Maestro System 3.0MM Diameter Implant (2003), 313 descendants of its own
- K041938: Maximus OS (Overdenture System) (2004), 271 descendants of its own
- K063364: Alpha Bio Dental Implant System (2007), 187 descendants of its own
- K081653: Mdi Mii One-Piece Implant, 2.9MM (2008), 141 descendants of its own
- K123022: Neodent Implant System (2013), 127 descendants of its own

## Recalls of this device
- Dec 10, 2013 · Class II · Z-1058-2014: The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.

## Indications for use
The Maestro SystemTM 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/K030463
Methodology: https://510kreport.com/methodology