# K032351: The Maestro System 3.0MM Diameter Implant

- Pathway: 510(k) (Traditional)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Oct 21, 2003 after 83 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). 13 ancestors in all.
313 later devices descend from it; 7 cite it directly.
0 of 327 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) Summary page 1.
- 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)
- K030463: Modification to the Maestro System, BioHorizons Implant Systems, Inc. (2003) Summary page 1.
- K992512: Altiva Corporation NTR 3.3 MM Self-Tapping Screw Implants, Altiva Corporation Corporation NTR-3.3 MM Self-Tapping HA Coa, Imcor (1999) Summary page 1.
- K972351: Sendax Mdi (Mini Dental Implant), Sendax Mdic Management, Inc. (1997) Summary page 1.
- K990983: Modification to Imtec Sendax Mdi, Imtec Corp. (1999) Summary page 1.
- K023067: Imtec Sendax Mdi ORTHO6 and ORTHO8, Imtec Corp. (2002) Summary page 1.

## Most influential descendants
- 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
- K133510: Neodent Implant System (2014), 123 descendants of its own

## Indications for use
The BioHorizons Maestro System 3.0 mm Diameter Implant may be used (1) as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implant may be immediately restored with a temporary prosthesis that is not in functional occlusion. (2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors. The implants may be restored after a period of time or placed in immediate function. (3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be restored after a period of time or placed in immediate function.

Source page: https://510kreport.com/device/K032351
Methodology: https://510kreport.com/methodology