Maestro System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K020645

Identifiers

510(k) Number: K020645 FDA 510(k)
FDA Product Code: DZE FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 872.3640 FDA 510(k)
Regulation Number: 872.3640 FDA 510(k)
Advisory Committee: Dental FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Maestro System is a screw-type dental implant system used as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention. It is made from titanium alloy and features either a resorbable blast media surface treatment or a synthetic hydroxylapatite coating.

The Maestro System is supplied for use in the mandible or maxilla. It is a single device with specific sizes and is regulated under the product code DZE, with FDA 510K authorization. The device is made by BioHorizons Implant Systems, Inc.

Frequently asked questions

What is the Maestro System used for?

The Maestro System is used as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention.

What material is the Maestro System made of?

The Maestro System is made from titanium alloy with either a resorbable blast media surface treatment or a synthetic hydroxylapatite coating.

Is the Maestro System supplied in different sizes?

Yes, the Maestro System is supplied in specific sizes for use in the mandible or maxilla.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MODIFICATION TO THE MAESTRO SYSTEM by BIOHORIZONS IMPLANT SYSTEMS, INC ..., MODIFICATION TO THE MAESTRO SYSTEM - Innolitics, MODIFICATION TO THE MAESTRO SYSTEM - Innolitics, Modification To The Maestro System 510 (k) FDA Premarket Notification ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K020645	Class II	Active

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Manufacturer

Manufacturer: BioHorizons Implant Systems, Inc.

Sources (1)

FDA 510(k) K020645 24 fields · synced Sep 24, 2026