# K972313: The Maestro System

- Pathway: 510(k) (Traditional)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Sep 16, 1997 after 88 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 K960026 (1996). 2 ancestors in all.
336 later devices descend from it; 6 cite it directly.
0 of 339 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964330: Biohorizons Dental Implant System (Name Subject to Change), BioHorizons Implant Systems, Inc. (1997) Summary page 3.
- (no number) Steri-Oss® Hex-Lock (HL) Threaded Titanium Implants: named in the summary without a submission number

## Most influential descendants
- K020133: Modification to the Maestro System (2002), 334 descendants of its own
- K020645: Modification to the Maestro System (2002), 333 descendants of its own
- K022795: Modification to the Maestro System (2002), 332 descendants of its own
- K030463: Modification to the Maestro System (2003), 331 descendants of its own
- K032351: The Maestro System 3.0MM Diameter Implant (2003), 313 descendants of its own

## Indications for use
The BioHorizons Maestro System™ is indicated for use as an artificial root structure for single tooth replacement or as abutments for bridgework and denture retention in the mandible and maxilla.

Source page: https://510kreport.com/device/K972313
Methodology: https://510kreport.com/methodology